Drug and Device Product Approvals for April 1996

                   ***ORIGINAL AND SUPPLEMENTAL NDAs***                              FOR NEW DRUG PRODUCTS19-537      CIPRO               BAYER             CIPROFLOXACIN HYDROCHLORIDE08-APR-96   (TABLET)            WEST HAVEN, CT    EQ 100MG BASE(SUPPL-026)                     06516             EQ 250MG BASE                                                  EQ 500MG BASE                                                  EQ 750MG BASE                                                  (NEW INDICATION --                                                  TREATMENT OF ACUTE                                                  UNCOMPLICATED CYSTITIS                                                  IN FEMALES)20-406      PREVACID            TAP HOLDINGS      LANSOPRAZOLE08-APR-96   (CAPSULE,           DEERFIELD, IL     15MG(SUPPL-002) DELAYED RELEASE)    60015             30MG            GRANULES                              (NEW INDICATION --                                                  MAINTENANCE OF                                                  HEALING                                                  OF EROSIVE                                                   ESOPHAGITIS)50-704      DAUNOXOME           NEXSTAR           DAUNORUBICIN CITRATE08-APR-96   (INJECTABLE,        SAN DIMAS, CA     EQ 2MG BASE/ML(3 P, AA*,  LIPOSOMAL)          91773             (ANTINEOPLASTIC)V**)                                              [FIRST LINE                                                   CYTOTOXIC                                                  THERAPY FOR ADVANCED HIV                                                  RELATED KAPOSI'S SARCOMA]                              19-810      PRILOSEC            ASTRA MERCK       OMEPRAZOLE15-APR-96   (CAPSULE,           WAYNE, PA         10MG(SUPPL-037) DELAYED RELEASE)    19087             20MG            GRANULES                              (NEW INDICATION --                                                  COMBINATION THERAPY WITH                                                  CLARITHROMYCIN TO ERADICATE                                                  HELICOBACTER PYLORI TO                                                   REDUCE THE RISK OF DUODENAL                                                  ULCER RECURRENCE)AA* - Priority Classification AIDS DrugV** - Designated Orphan Drug20-670      MONISTAT-3          ADV CARE          MICONAZOLE NITRATE16-APR-96   COMBINATION PACK    RARITAN, NJ       2% CREAM(6 S)       (CREAM/             08869             200MG SUPPOSITORY            SUPPOSITORY)                                      (ANTIFUNGAL)                                                  [TREATMENT OF VULVOVAGINAL                                                  CANDIDIASIS]                                                  (OTC)50-662      BIAXIN              ABBOTT            CLARITHROMYCIN18-APR-96   (TABLET)            ABBOTT PARK, IL   250MG(SUPPL-010)                     60064             500MG                                                  (NEW INDICATION --                                                  COMBINATION THERAPY WITH                                                  OMEPRAZOLE FOR THE                                                  TREATMENT OF PATIENTS WITH                                                  AN ACTIVE DUODENAL ULCER                                                  ASSOCIATED WITH                                                  HELICOBACTER PYLORI)18-731      BUSPAR              BRISTOL MYERS     BUSPIRONE HYDROCHLORIDE22-APR-96   (TABLET)            SQUIBB            5MG(SUPPL-031)                     WALLINGFORD, CT   10MG                                06492             15MG                                                  30MG***                                                  (NEW DOSAGE REGIMEN --                                                  DOSING SCHEDULE CHANGED                                                  TO BID AND INITIAL DOSE                                                  CHANGED TO 7.5MG)                                                                 20-472      ESTRING             PHARMACIA         ESTRADIOL26-APR-96   (INSERT,            COLUMBUS, OH      0.0075MG/24HR(3 S)       EXTENDED RELEASE)   43216             (ESTROGEN)                                                  [TREATMENT OF UROGENITAL                                                  SYMPTOMS ASSOCIATED WITH                                                  POST-MENOPAUSAL ATROPHY                                                  OF THE VAGINA AND/OR THE                                                  LOWER URINARY TRACT]20-528      MAVIK               KNOLL PHARM       TRANDOLAPRIL26-APR-96   (TABLET)            MOUNT OLIVE, NJ   1MG(1 S)                           07828             2MG                                                  4MG                                                  (ANGIOTENSIN CONVERTING                                                  ENZYME INHIBITOR)                                                  [TREATMENT OF HYPERTENSION]20-344      REDUX               INTERNEURON       DEXFENFLURAMINE29-APR-96   (CAPSULE)           LEXINGTON, MA     HYDROCHLORIDE(3 S)                           02173             15MG                                                  (SEROTONIN REUPTAKE                                                  INHIBITOR/RELEASING AGENT)                                                  [MANAGEMENT OF OBESITY]*** - Not Marketed At This Time20-573      BUPHENYL            UCYCLYD           SODIUM PHENYLBUTYRATE30-APR-96   (POWDER)            HUNT VALLEY, MD   3GM/TEASPOONFUL(1 P, V**)                      21031             (HYPERAMMONENMIA AGENT)                                                  [MANAGEMENT OF CHRONIC UREA                                                  CYCLE DISORDERS]V** - Designated Orphan Drug                         ***APPROVABLE ORIGINAL NDAs***An approvable letter indicates that FDA is prepared to approve the applicationupon the satisfaction of conditions specified in the approvable letter.Drug products which are the subject of approvable letters may not be legallymarketed until the firm has satisfied the identified deficiencies, as well asany other requirements that may be imposed by FDA, and has been notified inwriting that the application has been approved.  Further information onapprovable NDAs is not subject to Freedom of Information (FOI) release untilapplications are approved.20-524      BUTENAFINE HCL      PENEDERM          BUTENAFINE HYDROCHLORIDE03-APR-96   (CREAM)             FOSTER CITY, CA   1%                                94404             (ANTIFUNGAL)20-511      APHTHASOL           BLOCK DRUG        AMLEXANOX16-APR-96   (PASTE)             JERSEY CITY, NJ   5%                                07302             (ANTI-INFLAMMATORY)19-764      SAIZEN              SERONO LABS       SOMATROPIN, BIOSYNTHETIC22-APR-96   (INJECTABLE)        NORWELL, MA       5MG/VIAL                                02061             10MG/VIAL                                                  (HUMAN GROWTH HORMONE)20-589      CHILDREN'S ADVIL    WHITEHALL LABS    IBUPROFEN25-APR-96   (SUSPENSION)        MADISON, NJ       100MG/5ML                                07940             (NONSTEROIDAL                                                  ANTI-INFLAMMATORY)                                                  (OTC)20-602      JUNIOR STRENGTH     MCNEIL            IBUPROFEN25-APR-96   MOTRIN              FT WASHINGTON, PA 100MG            (TABLET)            19034             (NONSTEROIDAL                                                  ANTI-INFLAMMATORY)                                                  (OTC) 20-603      CHILDREN'S MOTRIN   MCNEIL            IBUPROFEN25-APR-96   (SUSPENSION)        FT WASHINGTON, PA 40MG/ML                                19034             (NONSTEROIDAL                                                  ANTI-INFLAMMATORY)                                                  (OTC) 20-591      TARKA               KNOLL PHARM       TRANDOLAPRIL26-APR-96   (TABLET)            MOUNT OLIVE, NJ   2MG                                07828             (ANGIOTENSIN CONVERTING                                                   ENZYME INHIBITOR)                                                  VERAPAMIL HYDROCHLORIDE                                                  180MG                                                  (CALCIUM CHANNEL BLOCKER)20-591      TARKA               KNOLL PHARM       TRANDOLAPRIL26-APR-96   (TABLET)            MOUNT OLIVE, NJ   4MG                                07828             (ANGIOTENSIN CONVERTING                                                   ENZYME INHIBITOR)                                                  VERAPAMIL HYDROCHLORIDE                                                  240MG                                                  (CALCIUM CHANNEL BLOCKER)                         ***ORIGINAL ABBREVIATED NDAs***20-345*     AMINOSYN-HF 8%      ABBOTT            AMINO ACIDS04-APR-96   (INJECTABLE)        ABBOTT PARK, IL   8%                                60064             (NUTRIENT REPLENISHER)20-360*     HEPATASOL 8%        BAXTER            AMINO ACIDS04-APR-96   (INJECTABLE)        ROUND LAKE, IL    8%                                60073             (NUTRIENT REPLENISHER)74-588*     MINOXIDIL           BARRE             MINOXIDIL05-APR-96   (FOR MEN)           BALTIMORE, MD     2%            (SOLUTION)          21224             (HAIR GROWTH STIMULANT)74-589*     MINOXIDIL           LEMMON            MINOXIDIL05-APR-96   (FOR MEN)           SELLERSVILLE, PA  2%            (SOLUTION)          18960             (HAIR GROWTH STIMULANT)74-643      MINOXIDIL           BAUSCH AND LOMB   MINOXIDIL09-APR-96   (FOR MEN)           TAMPA, FL         2%            (SOLUTION)          33637             (HAIR GROWTH STIMULANT)73-667      NORTRIPTYLINE HCL   BIOCRAFT          NORTRIPTYLINE HYDROCHLORIDE11-APR-96   (CAPSULE)           FAIR LAWN, NJ     EQ 10MG BASE                                07410             EQ 25MG BASE                                                  EQ 50MG BASE                                                  EQ 75MG BASE                                                  (ANTIDEPRESSANT)    74-216      NAPROXEN            BIOCRAFT          NAPROXEN11-APR-96   (TABLET)            FAIR LAWN, NJ     250MG                                07410             375MG                                                  500MG                                                  (NONSTEROIDAL                                                   ANTI-INFLAMMATORY)40-157      HYDROCODONE         VINTAGE PHARMS    ACETAMINOPHEN12-APR-96   BITARTRATE AND      CHARLOTTE, NC     750MG            ACETAMINOPHEN       28206             HYDROCODONE BITARTRATE            (TABLET)                              7.5MG                                                  (ANALGESIC)40-086*     UNIPHYL             PURDUE FREDERICK  THEOPHYLLINE15-APR-96   (TABLET,            NORWALK, CT       600MG            EXTENDED RELEASE)   06850             (BRONCHODILATOR)* - First Time Product Available Generically40-118*     CARISOPRODOL,       EON LABS          ASPIRIN16-APR-96   ASPIRIN AND         LAURELTON, NY     325MG            CODEINE PHOSPHATE   11413             CARISOPRODOL            (TABLET)                              200MG                                                  CODEINE PHOSPHATE                                                  16MG                                                    (ANALGESIC/                                                   SKELETAL MUSCLE RELAXANT)74-576      CAPTOPRIL           CHELSEA LABS      CAPTOPRIL23-APR-96   (TABLET)            CINCINNATI, OH    12.5MG                                45215             25MG                                                  50MG                                                  100MG                                                  (ANGIOTENSIN CONVERTING                                                   ENZYME INHIBITOR)40-092*     DIGOXIN PEDIATRIC   SANOFI WINTHROP   DIGOXIN25-APR-96   (INJECTABLE)        NEW YORK, NY      0.1MG/ML                                10016             (ANTIARRHYTHMIC/                                                  CARDIOTONIC)40-116      CARISOPRODOL        EON LABS          ASPIRIN25-APR-96   AND ASPIRIN         LAURELTON, NY     325MG            (TABLET)            11413             CARISOPRODOL                                                  200MG                                                  (ANALGESIC/                                                   SKELETAL MUSCLE RELAXANT)74-428      CIMETIDINE HCL      MOVA              CIMETIDINE HYDROCHLORIDE25-APR-96   (INJECTABLE)        CAGUAS, PR        EQ 300MG BASE/2ML                                00755             (HISTAMINE H-2 RECEPTOR                                                   ANTAGONIST)40-119      ACETAMINOPHEN AND   HI TECH PHARMA    ACETAMINOPHEN26-APR-96   CODEINE PHOSPHATE   AMITYVILLE, NY    120MG/5ML            (SOLUTION)          11701             CODEINE PHOSPHATE                                                  12MG/5ML                                                  (ANALGESIC)73-531      POTASSIUM CHLORIDE  BIOCRAFT          POTASSIUM CHLORIDE26-APR-96   (CAPSULE,           ELMWOOD PARK, NJ  8MEQ            EXTENDED RELEASE)   07407             (ELECTROLYTE REPLACEMENT)73-532      POTASSIUM CHLORIDE  BIOCRAFT          POTASSIUM CHLORIDE26-APR-96   (CAPSULE,           FAIR LAWN, NJ     10MEQ            EXTENDED RELEASE)   07410             (ELECTROLYTE REPLACEMENT)* - First Time Product Available Generically74-026      TRIAMTERENE AND     SIDMAK LABS NJ    HYDROCHLOROTHIAZIDE26-APR-96   HYDROCHLOROTHIAZIDE EAST HANOVER, NJ  25MG            (TABLET)            07936             TRIAMTERENE                                                  37.5MG                                                  (DIURETIC)74-299*+    INDAPAMIDE          ZENITH GOLDLINE   INDAPAMIDE29-APR-96   (TABLET)            NORTHVALE, NJ     1.25MG                                07647             (NEW STRENGTH)* - First Time Product Available Generically+ - Supplemental Abbreviated NDA      ***ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVAL***A tentative approval indicates that FDA has given an abbreviated new drugapplication (ANDA) or 505(b)(2) application provisional approval under theterms of the Drug Price Competition and Patent Term Restoration Act.  Suchdrugproducts that are the subjects of tentative approvals may not be legallymarketed until the market exclusivity and/or patent term of the listedreference drug product has expired.  Final approval is also contingent uponconditions and information available to FDA remaining acceptable.  When theapplication receives final approval, the product may be legally marketed.  Theeffective approval date will be listed in this publication and in the"Approved Drug Products with Therapeutic Equivalence Evaluations" listpublished by FDA. Additional information on these applications will become available to thepublic when the applications receive final approval.  THERE ARE NO ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALFOR APRIL 1996.                   ***LABELING SUPPLEMENTS TO ORIGINAL NDAs***20-262      TAXOL               BRISTOL MYERS SQUIBB PACLITAXEL01-APR-96   (INJECTABLE)        WALLINGFORD, CT      6MG/ML                                06492                (LABELING REVISION --                                                     BOXED WARNING;                                                     DESCRIPTION; WARNINGS;                                                     PRECAUTIONS;                                                     ADVERSE REACTIONS;                                                     DOSAGE AND                                                     ADMINISTRATION;                                                     HOW SUPPLIED)18-602      CARDIZEM            HOECHST MARION RSSL  DILTIAZEM HYDROCHLORIDE02-APR-96   (TABLET)            KANSAS CITY, MO      30MG                                64134                60MG                                                     90MG                                                     120MG                                                     (LABELING REVISION --                                                     WARNINGS;                                                     ADVERSE REACTIONS;                                                     OVERDOSAGE)19-951      RETROVIR            GLAXO WELLCOME       ZIDOVUDINE02-APR-96   (INJECTABLE)        RES TRIANGLE PK, NC  10MG/ML                                27709                (LABELING REVISION --                                                     CLINICAL PHARMACOLOGY;                                                     INDICATIONS AND USAGE;                                                     WARNINGS; PRECAUTIONS;                                                     ADVERSE REACTIONS;                                                     OVERDOSAGE;                                                     DOSAGE AND                                                     ADMINISTRATION)20-027      CARDIZEM            HOECHST MARION RSSL  DILTIAZEM HYDROCHLORIDE02-APR-96   (INJECTABLE)        KANSAS CITY, MO      5MG/ML                                64134                25MG/VIAL                                                     (LABELING REVISION --                                                     ADVERSE REACTIONS)20-033      LOTENSIN HCT        CIBA              BENAZEPRIL HYDROCHLORIDE02-APR-96   (TABLET)            SUMMIT, NJ        5MG                                07901             HYDROCHLOROTHIAZIDE                                                  6.25MG                                                  (LABELING REVISION --                                                  INDICATIONS AND USAGE;                                                  PRECAUTIONS;                                                  ADVERSE REACTIONS)20-033      LOTENSIN HCT        CIBA              BENAZEPRIL HYDROCHLORIDE02-APR-96   (TABLET)            SUMMIT, NJ        10MG                                07901             HYDROCHLOROTHIAZIDE                                                  12.5MG                                                  (LABELING REVISION --                                                  INDICATIONS AND USAGE;                                                  PRECAUTIONS;                                                  ADVERSE REACTIONS)20-033      LOTENSIN HCT        CIBA              BENAZEPRIL HYDROCHLORIDE02-APR-96   (TABLET)            SUMMIT, NJ        20MG                                07901             HYDROCHLOROTHIAZIDE                                                  12.5MG                                                  (LABELING REVISION --                                                  INDICATIONS AND USAGE;                                                  PRECAUTIONS;                                                  ADVERSE REACTIONS)20-033      LOTENSIN HCT        CIBA              BENAZEPRIL HYDROCHLORIDE02-APR-96   (TABLET)            SUMMIT, NJ        20MG                                07901             HYDROCHLOROTHIAZIDE                                                  25MG                                                  (LABELING REVISION --                                                  INDICATIONS AND USAGE;                                                  PRECAUTIONS;                                                  ADVERSE REACTIONS)20-062      CARDIZEM CD         CARDERM           DILTIAZEM HYDROCHLORIDE02-APR-96   (CAPSULE,           HAMILTON, BERMUDA 120MG            EXTENDED RELEASE)                     180MG                                                  240MG                                                  300MG                                                  (LABELING REVISION --                                                  WARNINGS;                                                  ADVERSE REACTIONS;                                                  OVERDOSAGE)17-892      HALCION             UPJOHN            TRIAZOLAM04-APR-96   (TABLET)            KALAMAZOO, MI     0.125MG                                49001             0.25MG                                                  (LABELING REVISION --                                                  CONTRAINDICATIONS;                                                  WARNINGS; PRECAUTIONS;                                                  PATIENT PACKAGE INSERT)18-584      BECONASE            GLAXO WELLCOME     BECLOMETHASONE DIPROPIONATE04-APR-96   (AEROSOL, METERED)  RES TRIANGLE PK, NC 0.042MG/INH                                27709               (LABELING REVISION --                                                    PRECAUTIONS;                                                    ADVERSE REACTIONS)50-668      LORABID             LILLY             LORACARBEF05-APR-96   (CAPSULE)           INDIANAPOLIS, IN  200MG                                46285             400MG                                                  (LABELING REVISION --                                                  SECTION(S) OF LABELING                                                  REVISED NOT SPECIFIED                                                  IN APPROVAL LETTER)                                                                   16-099      ATROMID-S           WYETH AYERST      CLOFIBRATE08-APR-96   (CAPSULE)           PHILADELPHIA, PA  500MG                                19101             (LABELING REVISION --                                                  WARNINGS; PRECAUTIONS;                                                  ADVERSE REACTIONS)19-537      CIPRO               BAYER             CIPROFLOXACIN HYDROCHLORIDE08-APR-96   (TABLET)            WEST HAVEN, CT    EQ 100MG BASE                                06516             EQ 250MG BASE                                                  EQ 500MG BASE                                                  EQ 750MG BASE                                                  (LABELING REVISION --                                                  INDICATIONS AND USAGE)20-406      PREVACID            TAP HOLDINGS      LANSOPRAZOLE08-APR-96   (CAPSULE,           DEERFIELD, IL     15MG            DELAYED RELEASE     60015             30MG            GRANULES)                             (LABELING REVISION --                                                  INDICATIONS AND USAGE)18-920*     MVI PEDIATRIC       ASTRA             ASCORBIC ACID09-APR-96   (INJECTABLE)        WESTBOROUGH, MA   80MG/VIAL                                01581             BIOTIN                                                  20MCG/VIAL                                                  CYANOCOBALAMIN                                                  1MCG/VIAL                                                  DEXPANTHENOL                                                  5MG/VIAL                                                  ERGOCALCIFEROL                                                  10MCG/VIAL                                                  FOLIC ACID                                                  140MCG/VIAL                                                  NIACINAMIDE                                                  17MG/VIAL                                                  PHYTONADIONE                                                  200MCG/VIAL                                                  PYRIDOXINE HYDROCHLORIDE                                                  EQ 1MG BASE/VIAL                                                  RIBOFLAVIN PHOSPHATE SODIUM                                                  EQ 1.4MG BASE/VIAL                                                  THIAMINE HYDROCHLORIDE                                                  EQ 1.2MG BASE/VIAL                                                  VITAMIN A                                                  0.7MG/VIAL                                                  VITAMINE E                                                  7MG/VIAL                                                  (LABELING REVISION --                                                  ADVERSE REACTIONS)16-832      CYLERT              ABBOTT            PEMOLINE11-APR-96   (TABLET)            ABBOTT PARK, IL   18.75MG                                60064             37.5MG                                                  75MG                                                  (LABELING REVISION --                                                  OVERDOSAGE)17-703      CYLERT              ABBOTT            PEMOLINE11-APR-96   (TABLET, CHEWABLE)  ABBOTT PARK, IL   37.5MG                                60064             (LABELING REVISION --                                                  OVERDOSAGE)  * - Not Marketed At This Time19-885      ACCUPRIL            PARKE DAVIS       QUINAPRIL HYDROCHLORIDE12-APR-96   (TABLET)            MORRIS PLAINS, NJ EQ 5MG BASE                                07950             EQ 10MG BASE                                                  EQ 20MG BASE                                                  EQ 40MG BASE                                                  (LABELING REVISION --                                                  INDICATIONS AND USAGE;                                                  WARNINGS;                                                  ADVERSE REACTIONS)09-053      PURINETHOL          GLAXO WELLCOME      MERCAPTOPURINE15-APR-96   (TABLET)            RES TRIANGLE PK, NC 50MG                                27709               (LABELING REVISION --                                                    WARNINGS)19-810      PRILOSEC            ASTRA MERCK       OMEPRAZOLE15-APR-96   (CAPSULE,           WAYNE, PA         10MG            DELAYED RELEASE     19087             20MG            GRANULES)                             (LABELING REVISION --                                                  CLINICAL PHARMACOLOGY;                                                  INDICATIONS AND USAGE;                                                  CONTRAINDICATIONS;                                                  PRECAUTIONS;                                                  ADVERSE REACTIONS;                                                  DOSAGE AND ADMINISTRATION)19-084      NIZORAL             JANSSEN           KETOCONAZOLE16-APR-96   (CREAM)             TITUSVILLE, NJ    2%                                08569             (LABELING REVISION --                                                  ADVERSE REACTIONS)           19-453      DRIXORAL            SCHERING PLOUGH   ACETAMINOPHEN16-APR-96   (TABLET,            MEMPHIS, TN       500MG            EXTENDED RELEASE)   38151             DEXBROMPHENIRAMINE MALEATE                                                  3MG                                                  PSEUDOEPHEDRINE SULFATE                                                  60MG                                                  (LABELING REVISION --                                                  PATIENT LABELING)                                                  (OTC)19-576      NIZORAL             JANSSEN           KETOCONAZOLE16-APR-96   (CREAM)             TITUSVILLE, NJ    2%                                08569             (LABELING REVISION --                                                  ADVERSE REACTIONS)  19-648      NIZORAL             JANSSEN           KETOCONAZOLE16-APR-96   (CREAM)             TITUSVILLE, NJ    2%                                08569             (LABELING REVISION --                                                  ADVERSE REACTIONS)           18-276      XANAX               UPJOHN            ALPRAZOLAM18-APR-96   (TABLET)            KALAMAZOO, MI     0.25MG                                49001             0.5MG                                                  1MG                                                  2MG                                                  (LABELING REVISION --                                                  CLINICAL PHARMACOLOGY;                                                  CONTRAINDICATIONS;                                                  WARNINGS; PRECAUTIONS)                 50-662      BIAXIN              ABBOTT            CLARITHROMYCIN18-APR-96   (TABLET)            ABBOTT PARK, IL   250MG                                60064             500MG                                                  (LABELING REVISION --                                                  INDICATIONS AND USAGE)20-280      GENOTROPIN          PHARMACIA         SOMATROPIN, BIOSYNTHETIC19-APR-96   (INJECTABLE)        COLUMBUS, OH      1.5MG/VIAL                                43216             5.8MG/VIAL                                                  (LABELING REVISION --                                                  HOW SUPPLIED)18-731      BUSPAR              BRISTOL MYERS SQUIBB BUSPIRONE HYDROCHLORIDE22-APR-96   (TABLET)            WALLINGFORD, CT      5MG                                06492                10MG                                                     15MG                                                     30MG*                                                     (LABELING REVISION --                                                     DESCRIPTION;                                                     ADVERSE REACTIONS;                                                     OVERDOSAGE;                                                     DOSAGE AND                                                     ADMINISTRATION;                                                     HOW SUPPLIED)19-279      DIMETANE            WYETH AYERST      BROMPHEMIRAMINE MALEATE22-APR-96   (SYRUP)             PHILADELPHIA, PA  2MG/5ML                                19101             DEXTROMETHORPHAN                                                  HYDROBROMIDE                                                  10MG/5ML                                                  PSEUDOEPHEDRINE                                                  HYDROCHLORIDE                                                  30MG/5ML                                                  (LABELING REVISION --                                                  CONTRAINDICATIONS;                                                  PRECAUTIONS)* - Not marketed at this time19-010      LUPRON              TAP               LEUPROLIDE ACETATE24-APR-96   (INJECTABLE)        DEERFIELD, IL     1MG/0.2ML                                60015             (LABELING REVISION --                                                  HOW SUPPLIED)20-186      ZIAC                LEDERLE           BISOPROLOL FUMARATE24-APR-96   (TABLET)            PHILADELPHIA, PA  2.5MG                                19101             HYDROCHLOROTHIAZIDE                                                  6.25MG                                                  (LABELING REVISION --                                                  OVERDOSAGE)20-186      ZIAC                LEDERLE           BISOPROLOL FUMARATE24-APR-96   (TABLET)            PHILADELPHIA, PA  5MG                                19101             HYDROCHLOROTHIAZIDE                                                  6.25MG                                                  (LABELING REVISION --                                                  OVERDOSAGE)20-186      ZIAC                LEDERLE           BISOPROLOL FUMARATE24-APR-96   (TABLET)            PHILADELPHIA, PA  10MG                                19101             HYDROCHLOROTHIAZIDE                                                  6.25MG                                                  (LABELING REVISION --                                                  OVERDOSAGE)                 19-927      NIZORAL             JANSSEN           KETOCONAZOLE 25-APR-96   (SHAMPOO)           TITUSVILLE, NJ    2%                                08569             (LABELING REVISION --                                                  OVERDOSAGE)50-708      PROGRAF             FUJISAWA          TACROLIMUS25-APR-96   (CAPSULE)           DEERFIELD, IL     EQ 1MG BASE                                60015             EQ 5MG BASE                                                  (LABELING REVISION --                                                  SECTION(S) OF LABELING                                                  REVISED NOT SPECIFIED                                                  IN APPROVAL LETTER)  50-709      PROGRAF             FUJISAWA          TACROLIMUS25-APR-96   (INJECTABLE)        DEERFIELD, IL     EQ 5MG BASE/ML                                60015             (LABELING REVISION --                                                  SECTION(S) OF LABELING                                                  REVISED NOT SPECIFIED                                                  IN APPROVAL LETTER)18-702      ACLOVATE            GLAXO WELLCOME      ALCLOMETASONE DIPROPIONATE26-APR-96   (OINTMENT)          RES TRIANGLE PK, NC 0.05%                                27709               (LABELING REVISION --                                                    CLASS LABELING UPDATE;                                                    PRECAUTIONS)18-707      ACLOVATE            GLAXO WELLCOME      ALCLOMETASONE DIPROPIONATE26-APR-96   (CREAM)             RES TRIANGLE PK, NC 0.05%                                27709               (LABELING REVISION --                                                    CLASS LABELING UPDATE;                                                    PRECAUTIONS)19-680      DEPAKOTE            ABBOTT            DIVALPROEX SODIUM26-APR-96   (CAPSULE,           ABBOTT PARK, IL   EQ 125MG VALPROIC ACID            DELAYED RELEASE     60064             (LABELING REVISION --            PELLETS)                              SECTION(S) OF LABELING                                                  REVISED NOT SPECIFIED                                                  IN APPROVAL LETTER)20-363      FAMVIR              SMITHKLINE BEECHAM FAMCICLOVIR26-APR-96   (TABLET)            PHILADELPHIA, PA   125MG                                19101              250MG                                                   500MG                                                    (LABELING REVISION --                                                   SECTION(S) OF LABELING                                                   REVISED NOT SPECIFIED                                                   IN APPROVAL LETTER)19-670      CLARITIN-D          SCHERING          LORATADINE29-APR-96   (TABLET,            KENILWORTH, NJ    5MG            EXTENDED RELEASE)   07033             PSEUDOEPHEDRINE SULFATE                                                  120MG                                                   (LABELING REVISION --                                                  SECTION(S) OF LABELING                                                  REVISED NOT SPECIFIED                                                  IN APPROVAL LETTER) 20-364      LOTREL              CIBA GEIGY        AMLODIPINE BESYLATE29-APR-96   (CAPSULE)           SUMMIT, NJ        EQ 2.5MG BASE                                07901             BENAZEPRIL HYDROCHLORIDE                                                  10MG                                                  (LABELING REVISION --                                                  INDICATIONS AND USAGE;                                                  PRECAUTIONS;                                                  ADVERSE REACTIONS)20-364      LOTREL              CIBA GEIGY        AMLODIPINE BESYLATE29-APR-96   (CAPSULE)           SUMMIT, NJ        EQ 5MG BASE                                07901             BENAZEPRIL HYDROCHLORIDE                                                  10MG                                                  (LABELING REVISION --                                                  INDICATIONS AND USAGE;                                                  PRECAUTIONS;                                                  ADVERSE REACTIONS)20-364      LOTREL              CIBA GEIGY        AMLODIPINE BESYLATE29-APR-96   (CAPSULE)           SUMMIT, NJ        EQ 5MG BASE                                07901             BENAZEPRIL HYDROCHLORIDE                                                  20MG                                                  (LABELING REVISION --                                                  INDICATIONS AND USAGE;                                                  PRECAUTIONS;                                                  ADVERSE REACTIONS)10-799      DIMETAPP ALLERGY    WHITEHALL         BROMPHENIRAMINE MALEATE30-APR-96   (TABLET,            MADISON, NJ       12MG            EXTENDED RELEASE)   07940             (LABELING REVISION --                                                  PATIENT LABELING)                                                  (OTC)                    ***BIOLOGICAL PRODUCT LICENSES ISSUED***1201        NONE                CANGENE            SOURCE PLASMA02-APR-96   (INJECTABLE)        WINNIPEG, MANITOBA (A,B)                                CANADA1138        REVERSE-CYTE        DADE AG           REAGENT RED BLOOD CELLS03-APR-96   (INJECTABLE)        SWITZERLAND       (B)0226        NONE                BLOOD BANK         PLATELETS25-APR-96   (INJECTABLE)        SAN BERNARDINO AND (B)                                RIVERSIDE COUNTIES                                SAN BERNARDINO, CA                                92412(A) Establishment License Issued(B) Product License Issued                    ***BIOLOGICAL PRODUCT DEVICE APPROVALS***BK960012    CYTO-THERM-S        PHOTO THERM       PLASMA THAWER15-APR-96                       TRENTON, NJ       (C)                                08610 BK960013    MTS CENTRIFUGE      MICRO TYPING SYS  CENTRIFUGE15-APR-96   MODEL #9310         POMPANO BEACH, FL (C)                                33069BK950033    HAEMONETICS PCS2    HAEMONETICS       APHERESIS HARDWARE16-APR-96                       BRAINTREE, MA     AND DISPOSABLE COLLECTION                                02184             SET                                                  (C)(C) Substantially Equivalent                      ***BIOLOGICAL PRODUCT NDA APPROVAL***83-071508   PROMIT              MEDISAN PHARMA    DEXTRAN 115-APR-96                       PARSIPPANY, NJ    (D)                                07054 (D) Approved             ***MEDICAL DEVICE - PREMARKET APPROVAL APPLICATIONS***THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICALHEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION RESOURCES PRIORTO PUBLICATIONP940005      ULTRAMARK 9         ADVANCED TECHNOLOGY AN ADJUNCT TO 04/11/96     HIGH DEFINITION     LABORATORIES        MAMMOGRAPHY AND PHYSICAL             IMAGING (HDI)       BOTHELL, WA         BREAST EXAMINATION, TO              ULTRASOUND SYSTEM   98041-3003          DIFFERENTIATE BENIGN             WITH L10-5                              FROM MALIGNANT OR              SCANHEAD                                SUSPICIOUS BREAST                                                     LESIONS                                                          P940042      SOLO-CARE           CIBA VISION CORP    FOR CLEANING, RINSING,04/25/96                         DULUTH, GA          DISINFECTING AND STORING                                 30136-1518          SOFT (HYDROPHILIC)                                                     CONTACT LENSES AND FOR                                                     DISSOLVING ENZYME                                                     TABLETS                    ***MEDICAL DEVICE - PMA SUPPLEMENTALS***THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICALHEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION RESOURCES PRIORTO PUBLICATIONN17786/S024  ALLERGAN            ALLERGAN OPTICAL    ALTERNATE CONTRACT   04/12/96     HYDROCARE           IRVINE, CA          STERILIZATION SITE,             CLEANING AND        92713-9534          ISOTRON IRELAND LTD.,              DISINFECTING                            OFFALY, IRELAND, AND             SOLUTION                                USE OF 100% ETHYLENE                                                     OXIDE TO STERILIZE                                                      PLASTIC BOTTLES,                                                       TIPS, AND CAPS     N18020/S039  ALLERGAN HYDROCARE  ALLERGAN OPTICAL    ALTERNATE CONTRACT   04/12/96     PRESERVED SALINE    IRVINE, CA          STERILIZATION SITE,               SOLUTION,           92713-9534          ISOTRON IRELAND LTD.,                SORBICARE SALINE,                       OFFALY, IRELAND, AND             AND PRESERVED                           USE OF 100% ETHYLENE             SALINE                                  OXIDE TO STERILIZE                                                     PLASTIC BOTTLES,                                                      TIPS, AND CAPSN50510/S070  VITEK SYSTEMS       BIOMERIEUX VITEK, INC ADDITION OF A        04/22/96     "GENERAL            HAZELWOOD, MO         LIMITATION STATEMENT             SUSCEPTIBILITY      63042-2395            REQUIRING AN ALTERNATE             CARD"                                     METHOD OF TESTING FOR                                                        PIPERACILIN IN                                                              SUSCEPTIBILITY TESTING                                                       OF PSEUDOMONAS                                                       AERUGINOSAP790002/S016 EBI BONE            ELECTRO-BIOLOGY, INC  LABELING CHANGES TO04/09/96     HEALING SYSTEM      PARSIPPANY, NJ        PHYSICIAN INSTRUCTION                                 07054-1079            AND PATIENT MANUALS                                                     P790017/S052 USCI GRUNTZIG,      C.R. BARD, INC      STERILIZATION SITE   04/18/96     FORCE, SPRINT,      BILLERICA, MA       CHANGE AND A CHANGE             AND SOLO BALLOON    01821               IN THE STERILIZATION             DILATATION CATHETER                     CYCLE                             WITH PRO/PEL COATINGP790024/S024 EASYCLEAN/GP,       ALLERGAN OPTICAL    ALTERNATE CONTRACT04/12/96     LC-65, LENS CLEAR,  IRVINE, CA          STERILIZATION SITE               AND LENS PLUS,      92715-9534          ISOTRON IRELAND LTD.,                DAILY CLEANERS                          OFFALY, IRELAND, AND USE                                                     OF 100% ETHYLENE OXIDE                                                     TO STERILIZE PLASTIC                                                     BOTTLES, TIPS, AND CAPS                                                                    P800065/S014 LENS-WET            ALLERGAN OPTICAL    ALTERNATE CONTRACT      04/12/96     LUBRICATING AND     IRVINE, CA          STERILIZATION SITE                 REWETTING SOLUTION  92713-9534          ISOTRON IRELAND LTD.,                AND LENS FRESH                          OFFALY, IRELAND, AND               LUBRICATING AND                         USE OF 100% ETHYLENE                  REWETTING DROPS                         OXIDE TO STERILIZE                                                         PLASTIC BOTTLES, TIPS,                                                     AND CAPS                P820018/S067 AUTIMA/AURORA       TELECTRONICS PACING APPROVAL FOR         04/23/96     CARDIAC PACING      SYSTEMS             SUBSTRATE DESIGN             SYSTEM              ENGLEWOOD, CO       CHANGES                                           80112                                                        P830026/S064 COSMOS FAMILY       INTERMEDICS, INC.   ALTERNATE            04/01/96     OF PULSE GENERATORS ANGLETON, TX        STERILIZATION PROCESS                                 77515 P830056/S075 POSTERIOR CHAMBER   MENTOR CORP.        APPROVAL FOR MODELS  04/02/96     INTRAOCULAR LENSES  SANTA BARBARA, CA   C420P, C540U, C445F,             (IOLS)              93111               C840U, U240F0, C540MC,                                                     U211F, AND U241FO                                                     POSTERIOR CHAMBER                                                     INTRAOCULAR LENSES                                                     VIA TIER A                                                                            P840008/S053 DORNIER             DORNIER MEDICAL     NEW MODEL LITHOTRIPTER04/11/96     LITHOTRIPTER MOBILE SYSTEMS, INC.       INDICATED FOR THE                                   KENNESAW, GA        FRAGMENTATION OF 5 TO 25                                 30144               MILLIMETER KIDNEY STONES                                                     SUCH AS RENAL CALYX AND                                                     AND RENAL PELVIC STONESP840024/S061 NUCLEUS 22          COCHLEAR CORP.      MODIFICATIONS TO THE 04/04/96     CHANNEL COCHLEAR    ENGLEWOOD, CO       AUDIO INPUT SELECTOR             IMPLANT SYSTEM      80112               (AIS), AN OPTIONAL                                                     ACCESSORY FOR THE                                                     NUCLEUS 22 CHANNEL                                                     COCHLEAR IMPLANT DEVICEP840068/S026 VISTA 4, 6, AND T;  GUIDANT CORP.       REPLACEMENT OF THE    04/16/96     DELTA T AND TRS;    ST. PAUL, MN        CURRENT CONNECTOR                 VISTA DDD; AND      55112-5798          TOP MATERIAL                     VIGOR DDD                         P850088/S033 OXYSEPT 1           ALLERGAN OPTICAL    ALTERNATE CONTRACT     04/12/96     AND ULTRACARE       IRVINE, CA          STERILIZATION SITE                 DISINFECTING        92713-9534          ISOTRON IRELAND LTD.,             SOLUTIONS AND                           OFFALY, IRELAND, AND USE             OXYSEPT 2                               OF 100% ETHYLENE OXIDE             NEUTRALIZING                            TO STERILIZE PLASTIC             SOLUTION                                BOTTLES, TIPS, AND CAPSP870007/S010 SORBIC ACID         OPTOPICS LABORATORIES TRANSFER OF PROCESSING04/22/96     PRESERVED STERILE   CORP.                 SITE FOR 100% ETHYLENE              SALINE FOR SOFT     FAIRTON, NJ           OXIDE STERILIZATION              CONTACT LENSES      08320-0210            (GLEN FALLS, NY)                                                                     P870026/S006 RESOLVE/GP          ALLERGAN OPTICAL    ALTERNATE CONTRACT     04/12/96     DAILY CLEANER       IRVINE, CA          STERILIZATION SITE                                     92715-9534          ISOTRON IRELAND LTD.,                                                     OFFALY, IRELAND AND USE                                                     OF 100% ETHYLENE OXIDE                                                     TO STERILIZE PLASTIC                                                        BOTTLES, TIPS, AND CAPSP870036/S036 VERSAFLEX           MEDTRONICS          REVISED LABELING     04/08/96     BUCHBINDER          INTERVENTIONAL             OMNIFLEX PTCA       SAN DIEGO, CA             CATHETER SYSTEM     92121-2256             MEDTRONIC 18K, 14K,             EVERGREEN, FALCON,             PANTHER, AND              PTCA CATHETERSP870037/S007 WET-N-SOAK          ALLERGAN OPTICAL    ALTERNATE CONTRACT     04/12/96     PLUS WETTING AND    IRVINE, CA          STERILIZATION SITE                  SOAKING SOLUTION    92715-9534          ISOTRON IRELAND LTD.,                                                        OFFALY, IRELAND AND USE                                                      OF 100% ETHYLENE OXIDE                                                     TO STERILIZE PLASTIC                                                       BOTTLES, TIPS, AND CAPSP880003/S053 CORDIS              CORDIS CORP.        DEVICE MODIFICATION;04/12/96     PERCUTANEOUS        MIAMI, FL           NEW TRADE NAME: CORDIS             TRANSLUMINAL        33102-5700          THOR PTCA CATHETER             CORONARY ANGIOPLASTY             (PTCA) DILATATION                                         CATHETERS                                    P880003/S055 CORDIS PTCA         CORDIS CORP.        DEVICE MODIFICATION;04/23/96     DILATATION CATHETER MIAMI, FL           NEW TRADE NAME: CORDIS             AND CORDIS VALOR    33102-5700          VALOR AND VALOR XL PTCA             AND VALOR XL PTCA                       CATHETERS             DILATATION CATHETERS                                                        P880003/S056 CORDIS PTCA          CORDIS CORP.       ADDITIONAL BALLOON SIZES04/23/96     DILATATION CATHETERS MIAMI, FL          FOR THE THOR PTCA             AND CORDIS THOR PTCA 33102-5700         DILATATION CATHETERS             DILATATION CATHETERS                    (2.75MM,3.25MM, AND                                                     AND 3.75MM DIAMETERS                                                     AND 30MM LENGTHS)                                             P880031/S009 AMO VITRAX          ALLERGAN MEDICAL    NEW STERILIZATION SITE04/09/96     VISCOELASTIC        OPTICS              (GRIFFITH MICRO SCIENCE,             SOLUTION            IRVINE, CA          GLEN FALLS, NY)                                 92713-9534          NEW STERILIZATION                                                     PROCESS (100% ETHYLENE                                                     OXIDE) FOR AMO VITRAX                                                     (SODIUM HYALURONATE)                                                      IN FINAL PACKAGINGP880031/S010 AMO VITRAX          ALLERGAN MEDICAL    USE OF               04/08/96     (SODIUM             OPTICS              "PHARMACEUTICAL             HYALURONATE)        IRVINE, CA          GRADE" SODIUM                                 92713-9534          HYALURONATE POWDER                                                     FROM ALTERNATE SUPPLIER                                                                          P880072/S039 MODEL PA48A-OUV     MEDICAL DEVELOPMENT MODELS PA48A-OUV VIA04/08/96     ULTRAVIOLET-        RESEARCH, INC.      TIER A MODIFICATION              ABSORBING           ST. PETERSBURG, FL                                POSTERIOR CHAMBER   33716                            INTRAOCULAR LENS                                          (IOL)                                                                                                  P880072/S040 MODELS GL65C-OUV    MEDICAL DEVELOPMENT MODELS GL65C-OUV AND04/17/96     AND PS50D-OUV       RESEARCH, INC.      PS50D-OUV VIA TIER A             ULTRAVIOLET-        ST. PETERSBURG, FL  MODIFICATION             ABSORBING           33716                            POSTERIOR CHAMBER                                         INTRAOCULAR               LENSES (IOLS)                                                                P880072/S042 POSTERIOR CHAMBER   MEDICAL DEVELOPMENT APPROVAL FOR TIER A  04/24/96     INTRAOCULAR LENSES  RESEARCH, INC.      POSTERIOR CHAMBER             MODELS PA38E-OUV    ST. PETERSBURG, FL  INTRAOCULAR LENSES             AND PL52A-OUV       33716               MODELS PA38E-OUV                                                         AND PL52A-OUVP880098/S009 SF-P                MENICON CO., LTD.   LABELING CHANGES     04/03/96     (MELAFOCON A)       WASHINGTON, D.C.    ADDITION OF ALLERGAN,             RIGID GAS PERMEABLE 20005               INC.'S DESTAT 4 SYSTEM             CONTACT LENS FOR                        AND ALCON LABORATORIES,             EXTENDED WEAR                           INC.'S OPTI-SOAK SYSTEM                                                                           P890025/S009 TDX/TDXFLX          ABBOTT LABORATORIES NEW PROBE CLEANING   04/01/96     CYCLOSPORINE        ABBOTT PARK, IL     PROCEDURE             MONOCLONAL          60064-3500             WHOLE BLOODP890027/S030 NUCLEUS 22          COCHLEAR CORP.      MODIFICATIONS TO THE 04/04/96     CHANNEL COCHLEAR    ENGLEWOOD, CO       AUDIO INPUT SELECTOR             IMPLANT             80112               (AIS), AN OPTIONAL                                                     ACCESSORY FOR THE                                                     NUCLEUS 22 CHANNEL                                                     COCHLEAR IMPLANT DEVICEP900009/S002 SONIC ACCELERATED   EXOGEN, INC.        NEW MANUFACTURING    04/02/96     FRACTURE HEALING    PISCATAWAY, NJ      FACILITY WHICH IS             SYSTEM MODEL 2A     08855               OWNED AND OPERATED BY                                                     HI-TRONICS DESIGNS,                                                      INC., AND LOCATED AT                                                     HACKETTSTOWN, NJ                                                      P900047/S003 WET-N-SOAK          ALLERGAN OPTICAL    ALTERNATE CONTRACT     04/12/96     REWETTING DROPS     IRVINE, CA          STERILIZATION SITE                                     92713-9534          ISOTRON IRELAND LTD.,                                                        OFFALY, IRELAND, AND USE                                                      OF 100% ETHYLENE OXIDE                                                     TO STERILIZE PLASTIC                                                     BOTTLES, TIPS, AND CAPS                                                          P900056/S015 ROTABLATOR          HEART TECHNOLOGY, INC. ELIMINATION OF THE   04/23/96     ROTATIONAL          REDMOND, WA            USP MOUSE SAFETY TEST             ANGIOPLASTY SYSTEM  98052-3376             AS A STERILIZATION                                                        LOAD RELEASE CRITERIA                      P900061/S013 MODEL 7219 B/D/E    MEDTRONIC, INC.     APPROVAL FOR MODEL   04/15/96     JEWEL, MODEL 7202   MINNEAPOLIS, MN     7219 B/D/E JEWEL,                 D/E JEWEL, MODEL    55432-3576          MODEL 7202 D/E/             7220 B/D/E JEWEL                        JEWEL, MODEL 7220                 PLUS DEVICE USED                        B/D/E JEWEL PLUS             WITH CPI ENDOTAK                        DEVICE WITH ENDOTAK             SERIES LEADS                            SERIES LEADSP910023/S016 CADENCE TIERED      VENTRITEX, INC.     APPROVAL TO STERILIZE04/26/96     THERAPY             SUNNYVALE, CA       VENTRITEX PRODUCTS AT             DEFIBRILLATOR       94086-6527          SOREX MEDICAL, INC.,             SYSTEM                                  USING CHAMBER 9P910073/S016 ENDOTAK SQ LEAD     GUIDANT CORP.       ALTERNATIVE          04/04/96     ARRAY MODEL 0048    ST. PAUL, MN        MANUFACTURING SITE:             AND ENDOTAK SQ      55112-5798          CARDIAC PACEMAKERS,             LEAD PATCH                              INC., DEL CARIBE,             MODEL 0063                              ROAD 698 LOT NO. 12,                                                     DORADO, PUERTO RICO                                                      00646P910073/S018 LEAD ADAPTER        GUIDANT CORP.       APPROVAL FOR LEAD    04/02/96     MODELS 6024,        ST. PAUL, MN        ADAPTER MODELS 6024,             6833, AND 6931      55112-5798          6833, 6931P910073/S019 MODEL 6952 LEAD     GUIDANT CORP.       MODEL 6952 LEAD      04/01/96     EXTENDER            ST. PAUL, MN        EXTENDER                                 55112-5798P910075/S005 COMPLETE BRAND      ALLERGAN OPTICAL    ALTERNATE CONTRACT     04/12/96     MULTI-PURPOSE       IRVINE, CA          STERILIZATION SITE                 SOLUTION AND        92713-9534          ISOTRON IRELAND LTD.,                COMPLETE BRAND                          OFFALY, IRELAND, AND USE             LUBRICATING AND                         OF 100% ETHYLENE OXIDE                REWETTING DROPS                         TO STERILIZE PLASTIC                                                     BOTTLES, TIPS, AND CAPS                                                        P920014/S003 TCI HEARTMATE       THERMO CARDIOSYSTEMS, CHANGE IN THE DESIGN 04/12/96     IP LVAS             INC.                  OF THE NON-BLOOD                                     WOBURN, MA            CONTACTING TITANIUM                                  01888-2697            COMPONENTS USED IN                                                        THE INFLOW AND                                                        OUTFLOW VALVE CONDUITS                                                       AND IN THE OUTFLOW                                                         GRAFT CONDUIT        P920015/S009 MEDTRONIC           MEDTRONIC, INC.       APPROVAL FOR THE     04/08/96     MODEL 6707          MINNEAPOLIS, MN       MODEL 6707 ADAPTER             ADAPTER             55432-3576P920032/S002 MICRO-PACE          PACE MEDICAL, INC.    APPROVAL FOR THE     04/26/96     MODEL 4553          WALTHAM, MA           PACESETTER, INC.,             DUAL DDD            02154                 MODEL 3070B PRIVATE             CHAMBER TEMPORARY                         LABEL VERSION OF THE             CARDIAC PACEMAKER                         PACE MEDICAL MODEL 4575P930012/S001 PROGRESSIVE         PROGRESSIVE           USE OF 100% ETHYLENE 04/02/96     ANGIOPLASTY         ANGIOPLASTY SYSTEMS   OXIDE STERILIZATION             SYSTEMS (PAS)       MENLO PARK, CA        TO BE PERFORMED AT             LACROSSE PTCA       94025                 MEDICAL MANUFACTURING             CORONARY                                  CORP., ERIE, PA                   DILATATION CATHETER                          P930012/S002 PROGRESSIVE         PROGRESSIVE           ADDITION OF 1.5MM    04/16/96     ANGIOPLASTY         ANGIOPLASTY SYSTEMS   DIAMETER, 20 MM             SYSTEMS (PAS)       MENLO PARK, CA        LENGTH BALLOON;             LACROSSE PTCA       94025-1516            ADDITION OF 2.5MM,             CORONARY                                  3.0MM, AND 4.0MM             DILATATION CATHETER                       BALLOONS                                                                  P940034/S001 GENPROBE            GEN-PROBE INC.        COMPONENT, SHELF     04/23/96     AMPLIFIED           SAN DIEGO, CA         LIFE, AND LABELING             MYCOBACTERIUM       92121                 CHANGES; NEW VENDOR             TUBERCULOSIS                              OF REVERSE             DIRECT (MTD) TEST                         TRANSCRIPTASEP950009/S001 AUTOPAP 300 QC      NEOPATH, INC.       CHANGE IN MANUAL TO  04/25/96     SYSTEM              REDMOND, WA         IMPROVE HOW THE REPORT                                 98052               FORMS WILL LOOK, FOR                                                     CLARITY                         ***ORIGINAL VETERINARY NADAs***141-043        SYNOVEX PLUS    CATTLE      SYNTEX AN HLTH ESTRADIOL BENZOATE22-FEB-96      (EAR IMPLANT)               PALO ALTO, CA  2.5MG                                            94304         TRENBOLONE ACETATE                                                          25MG                   ***ORIGINAL ABBREVIATED VETERINARY NADAs***200-170        NICARMIX 25   BROILER     PLANALQUIMICA IND LTDA  LINCOMYCIN02-APR-96      3-NITRO       CHICKENS    SAO PAULO, BRAZIL       HYDROCHLORIDE               LINCOMIX                                          4,20,50GM/LB               (TYPE A MEDICATED                                 NICARBAZIN               ARTICLES)                                         113.5GM/LB                                                                 ROXARSONE                                                                 10,20,50,80%200-171        NICARMIX 25   BROILER     PLANALQUIMICA IND LTDA  LINCOMYCIN02-APR-96      LINCOMIX      CHICKENS    SAO PAULO, BRAZIL       HYDROCHLORIDE               (TYPE A MEDICATED                                 4,20,50GM/LB               ARTICLES)                                         NICARBAZIN                                                                 113.5GM/LB200-172        NICARMIX 25   BROILER     PLANALQUIMICA IND LTDA  NICARBAZIN02-APR-96      3-NITRO       CHICKENS    SAO PAULO, BRAZIL       113.5GM/LB               (TYPE A MEDICATED                                 ROXARSONE               ARTICLES)                                         10,20,50,80%                       ***SUPPLEMENTAL VETERINARY NADAs***140-971        HEARTGARD-300 PLUS    DOGS        MERCK       IVERMECTIN15-FEB-96      (TABLET)                          RAHWAY, NJ  68MCG                                                 07065       PYRANTEL PAMOATE                                                             57MG