Drug and Device Product Approvals for February 1995

                      ***ORIGINAL AND SUPPLEMENTAL NDAs***                             FOR NEW DRUG PRODUCTS19-797     NULYTELY-FLAVORED       BRAINTREE            POLYETHYLENE GLYCOL 335018-NOV-94  (POWDER                 BRAINTREE, MA           420GM/BOT(SUPPL-002)FOR RECONSTITUTION)     02184                   POTASSIUM CHLORIDE                                                           1.48GM/BOT                                                           SODIUM BICARBONATE                                                           5.72GM/BOT                                                           SODIUM CHLORIDE                                                           11.2GM/BOT                                                       (GASTROINTESTINAL LAVAGE)20-356     NISOCOR                 MILES                   NISOLDIPINE02-FEB-95  (TABLET,                WEST HAVEN, CT          10MG(1 S)      EXTENDED RELEASE)       06516                   20MG                                                           30MG                                                           40MG                                                           (CALCIUM ION INFLUX                                                           INHIBITOR)                                                           [TREATMENT OF                                                                                                                                                                                                                                                   HYPERTENSION]20-371     CARDURA                 PFIZER                  DOXAZOSIN MESYLATE06-FEB-95  (TABLET)                NEW YORK, NY            EQ 1MG BASE(6 S)                              10017                   EQ 2MG BASE                                                           EQ 4MG BASE                                                           EQ 8MG BASE                                                         (ALPHA-1 ADRENORECEPTOR                                                                                                                        BLOCKER)                                                           [TREATMENT OF BENIGN                                                          PROSTATIC HYPERPLASIA]09-218     COUMADIN                DUPONT MERCK            WARFARIN SODIUM07-FEB-95  (INJECTABLE)            WILMINGTON, DE          5MG/VIAL(SUPPL-077)                        19880                   (ANTICOAGULANT)19-643     MEVACOR                 MERCK                   LOVASTATIN08-FEB-95  (TABLET)                WEST POINT, PA          10MG(SUPPL-034)                        19486                   20MG                                                                           40MG                                                           (NEW INDICATION --                                                         TO SLOW THE PROGRESSION                                                            OF CORONARY                                                                                                                                                                                                  ATHEROSCLEROSIS                                                       IN PATIENTS WITH CORONARY                                                           HEART DISEASE)                19-816     ORUVAIL                 WYETH AYERST            KETOPROFEN08-FEB-95  (CAPSULE,               RADNOR, PA              100MG(SUPPL-001)EXTENDED RELEASE)       19087                   150MG                                                           (NEW STRENGTHS)20-500     MEPRON                  BURROUGHS WELLC         ATOVAQUONE08-FEB-95  (SUSPENSION)            RES TRIANGLE PK, NC     750MG/5ML(3 P)                              27709                   (ANTIPROTOZOAL)                                                           [TREATMENT OF MILD TO                                                           MODERATE PNEUMOCYSTIS                                                           CARINII PNEUMONIA IN                                                           PATIENTS WHO ARE                                                            INTOLERANT TO                                                           TRIMETHOPRIM-                                                           SULFAMETHOXAZOLE]19-452     DERMA-SMOOTHE/FS        HILL DERMAC            FLUOCINOLONE ACETONIDE16-FEB-95  (OIL)                   ORLANDO, FL             0.01%(SUPPL-010)                        32814                   (NEW INDICATION --                                                         PSORIASIS OF THE SCALP)            17-806     THALLOUS                DUPONT               THALLOUS CHLORIDE,TL-20124-FEB-95  CHLORIDE TL 201         WILMINGTON, DE          1MCI/ML(SUPPL-022)(INJECTABLE)            19880                   (NEW INDICATION --                                                           SINGLE PHOTON                                                           EMISSION COMPUTED                                                            TOMOGRAPHY [SPECT])50-517     MEFOXIN                 MSD                     CEFOXITIN SODIUM28-FEB-95  (INJECTABLE)            WEST POINT, PA          EQ 1GM BASE/VIAL(SUPPL-029)                        19486                   EQ 2GM BASE/VIAL                                                           EQ 10GM BASE/VIAL                                                          (NEW DOSAGE REGIMEN --                                                          DELETION OF THREE DOSE                                                        REGIMEN FOR PROPHYLACTIC                                                      USE IN PATIENTS UNDERGOING                                                           CESAREAN SECTION)50-581     MEFOXIN                 MSD                     CEFOXITIN SODIUM28-FEB-95  IN PLASTIC CONTAINER    WEST POINT, PA          EQ 20MG BASE/ML(SUPPL-017)(INJECTABLE)            19486                   EQ 40MG BASE/ML                                                          (NEW DOSAGE REGIMEN --                                                          DELETION OF THREE-DOSE                                                        REGIMEN FOR PROPHYLACTIC                                                      USE IN PATIENTS UNDERGOING                                                           CESAREAN SECTION)50-662     BIAXIN                  ABBOTT                  CLARITHROMYCIN28-FEB-95  (TABLET)                ABBOTT PARK, IL         250MG(SUPPL-004)                        60064                   500MG                                                           (NEW INDICATION --                                                       ACUTE MAXILLARY SINUSITIS                                                           DUE TO HAEMOPHILUS                                                         INFLUENZAE OR MORAXELLA                                                           CATARRHALIS)                         ***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.20-313     MIACALCIN               SANDOZ                  CALCITONIN, SALMON10-FEB-95  (SPRAY, METERED)        EAST HANOVER, NJ        200IU/INH                                   07936                   (POLYPEPTIDE HORMONE)                                                           [POSTMENOPAUSAL                                                            OSTEOPOROSIS]20-377     CORDARONE               WYETH AYERST            AMIODARONE HCL10-FEB-9   (INJECTABLE)            PHILADELPHIA, PA        50MG/ML                                   19101                   (ANTIARRHYTHMIC)20-406     PREVACID                TAP                     LANSOPRAZOLE14-FEB-95  (CAPSULE,               DEERFIELD, IL           15MG           DELAYED RELEASE)        60015                   30MG                                                           (GASTRIC ACID                                                           SECRETION INHIBITOR)50-711     ZITHROMAX               PFIZER                 AZITHROMYCIN DIHYDRATE14-FEB-95  (TABLET)                GROTON, CT              EQ 250MG BASE                                   06340                 (ANTIBIOTIC, MACROLIDE)19-835     CETIRIZINE HCL          PFIZER               CETIRIZINE HYDROCHLORIDE21-FEB-95  (TABLET)                NEW YORK, NY            5MG                                   10017                   10MG                                                           (ANTIHISTAMINE)                        ***ORIGINAL ABBREVIATED NDAs***64-103     DAUNORUBICIN HCL        CETUS BEN VENUE    DAUNORUBICIN HYDROCHLORIDE03-FEB-95  (INJECTABLE)            EMERYVILLE, CA          EQ 20MG BASE/VIAL                                   94608                 (ANTIBIOTIC, ANTITUMOR)74-163     NAPROXEN                DANBURY PHARMA          NAPROXEN10-FEB-95  (TABLET)                DANBURY, CT             250MG                                   06810                   375MG                                                           500MG                                                           (NONSTEROIDAL                                                           ANTI-INFLAMMATORY)74-292     DOBUTAMINE HCL          SANOFI WINTHROP      DOBUTAMINE HYDROCHLORIDE16-FEB-95  (INJECTABLE)            NEW YORK, NY            EQ 12.5MG BASE/ML                                   10016                   (SYMPATHOMIMETIC/                                                      BETA-1 ADRENERGIC AGONIST)74-452     GEMFIBROZIL             MYLAN                   GEMFIBROZIL16-FEB-95  (TABLET)                MORGANTOWN, WV          600MG                                   26504                   (ANTIHYPERLIPIDEMIC)74-098     DOBUTAMINE HCL          ASTRA                DOBUTAMINE HYDROCHLORIDE21-FEB-95  (INJECTABLE)            WESTBOROUGH, MA         EQ 12.5MG BASE/ML                                   01581                   (SYMPATHOMIMETIC/                                                      BETA-1 ADRENERGIC AGONIST)74-127     ATENOLOL                MARTEC                  ATENOLOL21-FEB-95  (TABLET)                KANSAS CITY, MO         50MG                                   64120                   100MG                                                       (BETA ADRENERGIC BLOCKER)74-120     ATENOLOL                COPLEY PHARM            ATENOLOL24-FEB-95  (TABLET)                CANTON, MA              50MG                                   02021                   100MG                                                       (BETA ADRENERGIC BLOCKER)72-934     FLUOCINONIDE            FOUGERA                 FLUOCINONIDE27-FEB-95  (SOLUTION)              MELVILLE, NY            0.05%                                   11747                   (CORTICOSTEROID)73-106     ACETAMINOPHEN           ABLE                    ACETAMINOPHEN27-FEB-95  (SUPPOSITORY)           BALTIMORE, MD           120MG                                   21224                   (ANALGESIC)                                                               (OTC)73-107     ACETAMINOPHEN           ABLE                    ACETAMINOPHEN27-FEB-95  (SUPPOSITORY)           BALTIMORE, MD           325MG                                   21224                   (ANALGESIC)                                                               (OTC)73-108     ACETAMINOPHEN           ABLE                    ACETAMINOPHEN27-FEB-95  (SUPPOSITORY)           BALTIMORE, MD           650MG                                   21224                   (ANALGESIC)                                                               (OTC)74-166     TOPOSAR                 PHARMACIA               ETOPOSIDE27-FEB-95  (INJECTABLE)            COLUMBUS, OH            20MG/ML                                   43216                   (ANTINEOPLASTIC)74-223     GLIPIZIDE               WATSON LABS             GLIPIZIDE27-FEB-95  (TABLET)                CORONA, CA              5MG                                   91720                   10MG                                                       (BLOOD GLUCOSE REGULATOR)74-437     PINDOLOL                ROYCE LABS              PINDOLOL27-FEB-95  (TABLET)                MIAMI, FL               5MG                                   33014                   10MG                                                       (BETA ADRENERGIC BLOCKER)                            40-082     HEPARIN LOCK FLUSH      SANOFI WINTHROP         HEPARIN SODIUM28-FEB-95  (INJECTABLE)            NEW YORK, NY            10 UNITS/ML                                   10016                   100 UNITS/ML                                                           (ANTICOAGULANT)40-089*    ACETAZOLAMIDE SODIUM    BEDFORD                 ACETAZOLAMIDE SODIUM28-FEB-95  (INJECTABLE)            BEDFORD, OH             EQ 500MG BASE/VIAL                                   44146                   (CARBONIC ANHYDRASE                                                           INHIBITOR)* - First Time Product Available Generically63-336     DOXORUBICIN HCL         PHARMACHEMIE (NL)   DOXORUBICIN HYDROCHLORIDE28-FEB-95  (INJECTABLE)            HAARLEM, NETHERLANDS    2MG/ML                                                           200MG/100ML                                                         (ANTIBIOTIC, ANTITUMOR)73-306*    CLOTRIMAZOLE            LEMMON                  CLOTRIMAZOLE28-FEB-95  (SOLUTION)              SELLERSVILLE, PA        1%                                   18960                   (ANTIFUNGAL)74-111     NAPROXEN                ZENITH LABS             NAPROXEN28-FEB-95  (TABLET)                NORTHVALE, NJ           250MG                                   07647                   375MG                                                           500MG                                                           (NONSTEROIDAL                                                           ANTI-INFLAMMATORY)74-365     CIMETIDINE              LEMMON                  CIMETIDINE28-FEB-95  (TABLET)                SELLERSVILLE, PA        200MG                                   18960                   300MG                                                           400MG                                                           800MG                                                           (HISTAMINE                                                          H2-RECEPTOR ANTAGONIST)* - First Time Product Available Generically     ***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.  Such drug products 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 the application receives final approval, the product may be legally marketed.  Theeffective approval date will be listed in this publication and in the "ApprovedDrug Products with Therapeutic Equivalence Evaluations" list published by FDA.  Additional information on these applications will become available to thepublic when the applications receive final approval.74-047     ZIDOVUDINE              BARR                    ZIDOVUDINE24-FEB-95  (CAPSULE)               POMONA, NY              100MG                                   10970                   (ANTIVIRAL)                  ***LABELING SUPPLEMENTS TO ORIGINAL NDAs***17-970     NOLVADEX                ZENECA PHARMS           TAMOXIFEN CITRATE01-FEB-95  (TABLET)                WILMINGTON, DE          EQ 10MG BASE                                   19850                   (LABELING REVISION --                                                           WARNINGS)                   20-055     GLYBURIDE (MICRONIZED)  HOECHST ROUSSEL         GLYBURIDE01-FEB-95  (TABLET)                SOMERVILLE, NJ          1.5MG                                   08876                   3MG                                                           (LABELING REVISION --                                                         DELETION OF TRADE NAME;                                                       DESCRIPTION; PRECAUTIONS;                                                           ADVERSE REACTIONS;                                                      DOSAGE AND ADMINISTRATION;                                                           HOW SUPPLIED)18-303     LOPRESSOR HCT 50/25     CIBA                    HYDROCHLOROTHIAZIDE02-FEB-95  (TABLET)                SUMMIT, NJ              25MG                                   07901                   METOPROLOL TARTRATE                                                           50MG                                                           (LABELING REVISION --                                                       DESCRIPTION; PRECAUTIONS)                                                                      18-303     LOPRESSOR HCT 100/25    CIBA                    HYDROCHLOROTHIAZIDE02-FEB-95  (TABLET)                SUMMIT, NJ              25MG                                   07901                   METOPROLOL TARTRATE                                                           100MG                                                           (LABELING REVISION --                                                       DESCRIPTION; PRECAUTIONS)       18-303     LOPRESSOR HCT 100/50    CIBA                    HYDROCHLOROTHIAZIDE02-FEB-95  (TABLET)                SUMMIT, NJ              50MG                                   07901                   METOPROLOL TARTRATE                                                           100MG                                                           (LABELING REVISION --                                                       DESCRIPTION; PRECAUTIONS)            19-508     AXID                    ELI LILLY               NIZATIDINE02-FEB-95  (CAPSULE)               INDIANAPOLIS, IN        150MG                                   46285                   300MG                                                                              (LABELING REVISION --                                                           PRECAUTIONS;                                                           ADVERSE REACTIONS;                                                           HOW SUPPLIED)17-553     PROGESTASERT            ALZA                    PROGESTERONE03-FEB-95  (INSERT,                PALO ALTO, CA           38MG           EXTENDED RELEASE)       94303                   (LABELING REVISION --                                                           STD STATEMENT;                                                         PATIENT PACKAGE INSERT)20-071     DESOGEN                 ORGANON                 DESOGESTREL03-FEB-95  (TABLET-28 DAY)         WEST ORANGE, NJ         0.15MG                                   07052                   ETHINYL ESTRADIOL                                                           0.03MG                                                           (LABELING REVISION --                                                           STD STATEMENT;                                                                                                                                                                                               PRECAUTIONS;                                                         PATIENT PACKAGE INSERT)17-997     ULTRALENTE INSULIN      NOVO NORDISK            INSULIN ZINC SUSP 06-FEB-95  (INJECTABLE)            PRINCETON, NJ           EXTENDED BEEF                                   08540                   100 UNITS/ML                                                           (LABELING REVISION --                                                       LETTER INFORMING PATIENTS                                                           OF IMMEDIATE                                                                                                                                                                                                 DISCONTINUATION                                                           OF THIS PRODUCT) 19-668     CARDURA                 PFIZER LABS             DOXAZOSIN MESYLATE06-FEB-95  (TABLET)                NEW YORK, NY            EQ 1MG BASE                                   10017                   EQ 2MG BASE                                                           EQ 4MG BASE                                                           EQ 8MG BASE                                                           (LABELING REVISION --                                                          CLINICAL PHARMACOLOGY;                                                          INDICATIONS AND USAGE;                                                          WARNINGS; PRECAUTIONS;                                                           ADVERSE REACTIONS;                                                           OVERDOSAGE;                                                      DOSAGE AND ADMINISTRATION)                   50-558     ZINACEF                 GLAXO                   CEFUROXIME SODIUM06-FEB-95  (INJECTABLE)            RES TRIANGLE PK, NC     EQ 750MG BASE/VIAL                                   27709                   EQ 1.5GM BASE/VIAL                                                           EQ 7.5GM BASE/VIAL                                                           (LABELING REVISION --                                                           ADVERSE REACTIONS)50-643     ZINACEF                 GLAXO                   CEFUROXIME SODIUM06-FEB-95  IN PLASTIC CONTAINER    RES TRIANGLE PK, NC     EQ 15MG BASE/ML           (INJECTABLE)            27709                   EQ 30MG BASE/ML                                                           (LABELING REVISION --                                                           ADVERSE REACTIONS)09-218     COUMADIN                DUPONT MERCK            WARFARIN SODIUM07-FEB-95  (INJECTABLE)            WILMINGTON, DE          5MG/VIAL                                   19880                   (LABELING REVISION --                                                           DESCRIPTION;                                                          CLINICAL PHARMACOLOGY;                                                           DOSAGE AND LABORATORY                                                          CONTROL; HOW SUPPLIED)09-218     COUMADIN                DUPONT MERCK            WARFARIN SODIUM07-FEB-95  (TABLET)                WILMINGTON, DE          1MG                                   19880                   2MG                                                           2.5MG                                                           4MG                                                           5MG                                                           7.5MG                                                           10MG                                                           (LABELING REVISION --                                                           DESCRIPTION;                                                          CLINICAL PHARMACOLOGY;                                                           DOSAGE AND LABORATORY                                                          CONTROL; HOW SUPPLIED)14-214     NEGGRAM                 SANOFI WINTHROP         NALIDIXIC ACID07-FEB-95  (TABLET)                NEW YORK, NY            250MG                                   10016                   500MG                                                           1GM                                                           (LABELING REVISION --                                                          INDICATIONS AND USAGE;                                                           PRECAUTIONS;                                                           ANIMAL PHARMACOLOGY)17-430     NEGGRAM                 SANOFI WINTHROP         NALIDIXIC ACID07-FEB-95  (SUSPENSION)            NEW YORK, NY            250MG/5ML                                   10016                   (LABELING REVISION --                                                          INDICATIONS AND USAGE;                                                           PRECAUTIONS;                                                           ANIMAL PHARMACOLOGY)13-553     ESIMIL                  CIBA                 GUANETHIDINE MONOSULFATE08-FEB-95  (TABLET)                SUMMIT, NJ              10MG                                   07901                   HYDROCHLOROTHIAZIDE                                                           25MG                                                           (LABELING REVISION --                                                           PRECAUTIONS)17-962     PARLODEL                SANDOZ                 BROMOCRIPTINE MESYLATE08-FEB-95  (TABLET)                EAST HANOVER, NJ        EQ 2.5MG BASE                                   07936                   EQ 5MG BASE                                                           (LABELING REVISION --                                                           CONTRAINDICATIONS;                                                           WARNINGS)                   18-754     ORUDIS                  WYETH AYERST            KETOPROFEN08-FEB-95  (CAPSULE)               PHILADELPHIA, PA        25MG                                   19101                   50MG                                                           75MG                                                           (LABELING REVISION --                                                           ADVERSE REACTIONS)19-643     MEVACOR                 MERCK                   LOVASTATIN08-FEB-95  (TABLET)                WEST POINT, PA          10MG                                   19486                   20MG                                                           40MG                                                           (LABELING REVISION --                                                          CLINICAL PHARMACOLOGY;                                                          INDICATIONS AND USAGE)19-715     DIPENTUM                PHARMACIA               OLSALAZINE SODIUM08-FEB-95  (CAPSULE)               COLUMBUS, OH            250MG                                   43216                   (LABELING REVISION --                                                           ADVERSE REACTIONS)19-816     ORUVAIL                 WYETH AYERST            KETOPROFEN08-FEB-95  (CAPSULE,               RADNOR, PA              200MG           EXTENDED RELEASE)       19087                   (LABELING REVISION --                                                           ADVERSE REACTIONS)20-098     MIVACRON                BURROUGHS WELLC         MIVACURIUM CHLORIDE08-FEB-95  (INJECTABLE)            RES TRIANGLE PK, NC     EQ 2MG BASE/ML                                   27709                   (LABELING REVISION --                                                           ADVERSE REACTIONS)20-098     MIVACRON                BURROUGHS WELLC         MIVACURIUM CHLORIDE08-FEB-95  IN DEXTROSE 5%          RES TRIANGLE PK, NC     EQ 0.5MG BASE/ML           IN PLASTIC CONTAINER    27709                   EQ 50MG BASE/100ML           (INJECTABLE)                                    (LABELING REVISION --                                                            ADVERSE REACTIONS)                                                                 50-664     CEFZIL                  BRISTOL MYERS SQUIBB    CEFPROZIL08-FEB-95  (TABLET)                WALLINGFORD, CT         250MG                                   06492                   500MG                                                           (LABELING REVISION --                                                            DESCRIPTION;                                                           ADVERSE REACTIONS;                                                           HOW SUPPLIED)50-665     CEFZIL                  BRISTOL MYERS SQUIBB    CEFPROZIL08-FEB-95  (POWDER                 WALLINGFORD, CT         125MG/5ML           FOR RECONSTITUTION)     06492                   250MG/5ML                                                           (LABELING REVISION --                                                           DESCRIPTION;                                                           ADVERSE REACTIONS;                                                           HOW SUPPLIED) 17-450     MONISTAT 7              ORTHO PHARM             MICONAZOLE NITRATE09-FEB-95  (CREAM)                 RARITAN, NJ             2%                                   08869                   (LABELING REVISION --                                                           PATIENT LABELING)                                                               (OTC)19-450     VELOSULIN HUMAN         NOVO NORDISK            INSULIN SEMISYNTHETIC09-FEB-95  (INJECTABLE)            PRINCETON, NJ           PURIFIED HUMAN                                   08540                   100 UNITS/ML                                                           (LABELING REVISION --                                                           PATIENT LABELING)                                                               (OTC)18-230     MYCELEX-7               MILES                   CLOTRIMAZOLE 13-FEB-95  (CREAM)                 W HAVEN, CT             1%                                   06516                   (LABELING REVISION --                                                           PATIENT LABELING)                                                               (OTC)50-405     KEFLEX                  ELI LILLY               CEPHALEXIN13-FEB-95  (CAPSULE)               INDIANAPOLIS, IN        EQ 250MG BASE                                   46285                   EQ 500MG BASE                                                           (LABELING REVISION --                                                          CLINICAL PHARMACOLOGY)50-406     KEFLEX                  ELI LILLY               CEPHALEXIN13-FEB-95  (POWDER                 INDIANAPOLIS, IN        EQ 125MG BASE/5ML           FOR RECONSTITUTION)     46285                   EQ 250MG BASE/5ML                                                           (LABELING REVISION --                                                          CLINICAL PHARMACOLOGY)        06-309     KWELL                   REED AND CARNRICK       LINDANE16-FEB-95  (CREAM)                 JERSEY CITY, NJ         1%                                   07302                   (LABELING REVISION --                                                          WARNINGS; PRECAUTIONS;                                                           CONTRAINDICATIONS;                                                           ADVERSE REACTIONS;                                                           DIRECTIONS FOR USE)06-309     KWELL                   REED AND CARNRICK       LINDANE16-FEB-95  (LOTION)                JERSEY CITY, NJ         1%                                   07302                   (LABELING REVISION --                                                          WARNINGS; PRECAUTIONS;                                                           CONTRAINDICATIONS;                                                           ADVERSE REACTIONS;                                                           DIRECTIONS FOR USE)10-718     KWELL                   REED AND CARNRICK       LINDANE16-FEB-95  (SHAMPOO)               JERSEY CITY, NJ         1%                                   07302                   (LABELING REVISION --                                                           WARNINGS;                                                            PRECAUTIONS;                                                           CONTRAINDICATIONS;                                                           ADVERSE REACTIONS;                                                           DIRECTIONS FOR USE)19-452     DERMA-SMOOTHE/FS        HILL DERMAC            FLUOCINOLONE ACETONIDE16-FEB-95  (OIL)                   ORLANDO, FL             0.01%                                   32814                   (LABELING REVISION --                                                          INDICATIONS AND USAGE)19-766     ZOCOR                   MERCK                   SIMVASTATIN16-FEB-95  (TABLET)                WEST POINT, PA          5MG                                   19486                   10MG                                                           20MG                                                           40MG                                                           (LABELING REVISION --                                                      DOSAGE AND ADMINISTRATION)20-090     DIFLUCAN                PFIZER                  FLUCONAZOLE21-FEB-95  (POWDER FOR             NEW YORK, NY            50MG/5ML           RECONSTITUTION)         10017                   200MG/5ML                                                           (LABELING REVISION --                                                          CLINICAL PHARMACOLOGY;                                                           PRECAUTIONS;                                                           ADVERSE REACTIONS;                                                      DOSAGE AND ADMINISTRATION)07-883     ANTABUSE                WYETH AYERST            DISULFIRAM21-FEB-95  (TABLET)                PHILADELPHIA, PA        250MG                                   19101                   500MG                                                           (LABELING REVISION --                                                           ADVERSE REACTIONS)            50-162     CLEOCIN HCL             UPJOHN              CLINDAMYCIN HYDROCHLORIDE21-FEB-95  (CAPSULE)               KALAMAZOO, MI           EQ 75MG BASE                                   49001                   EQ 150MG BASE                                                           EQ 300MG BASE                                                           (LABELING REVISION --                                                           WARNINGS; ADVERSE                                                                                                                                                                                            REACTIONS)                   50-441     CLEOCIN PHOSPHATE       UPJOHN                  CLINDAMYCIN PHOSPHATE21-FEB-95  (INJECTABLE)            KALAMAZOO, MI           EQ 150MG BASE/ML                                   49001                   (LABELING REVISION --                                                           WARNINGS; ADVERSE                                                                                                                                                                                            REACTIONS)50-639     CLEOCIN PHOSPHATE       UPJOHN                  CLINDAMYCIN PHOSPHATE21-FEB-95  IN DEXTROSE 5%          KALAMAZOO, MI           EQ 6MG BASE/ML           IN PLASTIC CONTAINER    49001                   EQ 12MG BASE/ML           (INJECTABLE)                                    EQ 18MG BASE/ML                                                           (LABELING REVISION --                                                           WARNINGS; ADVERSE                                                                                                                                                                                            REACTIONS)17-920     TAGAMET                 SMITHKLINE BEECHAM      CIMETIDINE22-FEB-95  (TABLET)                PHILADELPHIA, PA        200MG                                   19101                   300MG                                                           400MG                                                           800MG                                                           (LABELING REVISION --                                                       DESCRIPTION; PRECAUTIONS;                                                           ADVERSE REACTIONS;                                                           HOW SUPPLIED)                17-924     TAGAMET                 SMITHKLINE BEECHAM   CIMETIDINE HYDROCHLORIDE22-FEB-95  (SOLUTION)              PHILADELPHIA, PA        EQ 300MG BASE/5ML                                   19101                   (LABELING REVISION --                                                       DESCRIPTION; PRECAUTIONS;                                                           ADVERSE REACTIONS;                                                           HOW SUPPLIED)17-939     TAGAMET                 SMITHKLINE BEECHAM   CIMETIDINE HYDROCHLORIDE22-FEB-95  (INJECTABLE)            PHILADELPHIA, PA        EQ 300MG BASE/2ML                                   19101                   (LABELING REVISION --                                                       DESCRIPTION; PRECAUTIONS;                                                           ADVERSE REACTIONS;                                                           HOW SUPPLIED)                                                                   18-537     TRIDIL                  DUPONT MERCK            NITROGLYCERIN22-FEB-95  (INJECTABLE)            GARDEN CITY, NY         0.5MG/ML                                   11530                   5MG/ML                                                           (LABELING REVISION --                                                           ADVERSE REACTIONS)18-780     HUMULIN R               LILLY              INSULIN BIOSYNTHETIC HUMAN22-FEB-95  (INJECTABLE)            INDIANAPOLIS, IN        100 UNITS/ML                                   46285                   (LABELING REVISION --                                                           INFORMATION FOR THE                                                                                                                                                                                          PATIENT)                                                               (OTC)18-781     HUMULIN N               LILLY                   INSULIN SUSP ISOPHANE22-FEB-95  (INJECTABLE)            INDIANAPOLIS, IN        BIOSYNTHETIC HUMAN                                   46285                   100 UNITS/ML                                                           (LABELING REVISION --                                                           INFORMATION FOR THE                                                                                                                                                                                          PATIENT)                                                               (OTC)18-841     DAYPRO                  SEARLE                  OXAPROZIN22-FEB-95  (TABLET)                SKOKIE, IL              600MG                                   60077                   (LABELING REVISION --                                                           ADVERSE REACTIONS)19-377     HUMULIN L               LILLY                   INSULIN ZINC SUSP22-FEB-95  (INJECTABLE)            INDIANAPOLIS, IN        BIOSYNTHETIC HUMAN                                   46285                   100 UNITS/ML                                                           (LABELING REVISION --                                                           INFORMATION FOR THE                                                                                                                             PATIENT)                                                               (OTC)                                                                      19-434     TAGAMET HCL             SMITHKLINE BEECHAM   CIMETIDINE HYDROCHLORIDE22-FEB-95  IN SODIUM CHLORIDE 0.9% PHILADELPHIA, PA        EQ 6MG BASE/ML           IN PLASTIC CONTAINER    19101                   (LABELING REVISION --           (INJECTABLE)                                DESCRIPTION; PRECAUTIONS;                                                           ADVERSE REACTIONS;                                                           HOW SUPPLIED) 19-558     PRINIVIL                MERCK                   LISINOPRIL22-FEB-95  (TABLET)                WEST POINT, PA          2.5MG                                   19486                   5MG                                                           10MG                                                           20MG                                                           40MG                                                           (LABELING REVISION --                                                           ADVERSE REACTIONS;                                                      DOSAGE AND ADMINISTRATION)19-571     HUMULIN U               LILLY              INSULIN ZINC SUSP EXTENDED22-FEB-95  (INJECTABLE)            INDIANAPOLIS, IN        BIOSYNTHETIC HUMAN                                   46285                   100 UNITS/ML                                                           (LABELING REVISION --                                                           INFORMATION FOR THE                                                                                                                                                                                          PATIENT)                                                                                                                                                                                                              (OTC)19-717     HUMULIN 70/30           LILLY              INSULIN BIOSYNTHETIC HUMAN22-FEB-95  (INJECTABLE)            INDIANAPOLIS, IN        30 UNITS/ML                                   46285                   INSULIN SUSP ISOPHANE                                                           BIOSYNTHETIC HUMAN                                                           70 UNITS/ML                                                           (LABELING REVISION --                                                           INFORMATION FOR THE                                                                                                                                                                                          PATIENT)                                                               (OTC)                   19-778     PRINZIDE 10-12.5        MERCK                   HYDROCHLOROTHIAZIDE22-FEB-95  (TABLET)                WEST POINT, PA          12.5MG                                   19486                   LISINOPRIL                                                           10MG                                                           (LABELING REVISION --                                                           ADVERSE REACTIONS)19-778     PRINZIDE 20-12.5        MERCK                   HYDROCHLOROTHIAZIDE22-FEB-95  (TABLET)                WEST POINT, PA          12.5MG                                   19486                   LISINOPRIL                                                           20MG                                                           (LABELING REVISION --                                                           ADVERSE REACTIONS)19-778     PRINZIDE 20-25          MERCK                   HYDROCHLOROTHIAZIDE22-FEB-95  (TABLET)                WEST POINT, PA          25MG                                   19486                   LISINOPRIL                                                           20MG                                                           (LABELING REVISION --                                                           ADVERSE REACTIONS)            20-100     HUMULIN 50/50           LILLY              INSULIN BIOSYNTHETIC HUMAN22-FEB-95  (INJECTABLE)            INDIANAPOLIS, IN        50 UNITS/ML                                   46285                   INSULIN SUSP ISOPHANE                                                           BIOSYNTHETIC HUMAN                                                           50 UNITS/ML                                                           (LABELING REVISION --                                                           INFORMATION FOR THE                                                                                                                                                                                         PATIENT)                                                               (OTC)18-748     LOPROX                  HOECHST ROUSSEL         CICLOPIROX OLAMINE23-FEB-95  (CREAM)                 SOMERVILLE, NJ          1%                                   08766                   (LABELING REVISION --                                                           PRECAUTIONS)19-824     LOPROX                  HOECHST ROUSSEL         CICLOPIROX OLAMINE23-FEB-95  (LOTION)                SOMERVILLE, NJ          1%                                   08766                   (LABELING REVISION --                                                           PRECAUTIONS)                  20-031     PAXIL                   SMITHKLINE BEECHAM   PAROXETINE HYDROCHLORIDE23-FEB-95  (TABLET)                KING OF PRUSSIA, PA     EQ 20MG BASE                                   19406                   EQ 30MG BASE                                                           (LABELING REVISION --                                                           ADVERSE REACTIONS;                                                           PRECAUTIONS)                20-226     NAPHCON-A               ALCON               NAPHAZOLINE HYDROCHLORIDE23-FEB-95  (SOLUTION)              FORT WORTH, TX          0.025%                                   76115                   PHENIRAMINE MALEATE                                                           0.3%                                                           (LABELING REVISION --                                                           PATIENT LABELING)                                                               (OTC)17-806     THALLOUS                DUPONT              THALLOUS CHLORIDE, TL-20124-FEB-95  CHLORIDE TL 201         WILMINGTON, DE          1MCI/ML           (INJECTABLE)            19880                   (LABELING REVISION --                                                           DESCRIPTION;                                                          INDICATIONS AND USAGE;                                                           PRECAUTIONS;                                                           ADVERSE REACTIONS;                                                      DOSAGE AND ADMINISTRATION)18-086     TIMOPTIC                MERCK                   TIMOLOL MALEATE24-FEB-95  (SOLUTION/DROPS)        WEST POINT, PA          EQ 0.25% BASE                                   19486                   EQ 0.5% BASE                                                           (LABELING REVISION --                                                          INDICATIONS AND USAGE;                                                           PRECAUTIONS;                                                           ADVERSE REACTIONS;                                                           OVERDOSAGE)18-751     SPECTAZOLE              JOHNSON RW              ECONAZOLE NITRATE24-FEB-95  (CREAM)                 RARITAN, NJ             1%                                   08869                   (LABELING REVISION --                                                          CLINICAL PHARMACOLOGY)                                                                   50-517     MEFOXIN                 MSD                     CEFOXITIN SODIUM28-FEB-95  (INJECTABLE)            WEST POINT, PA          EQ 1GM BASE/VIAL                                   19486                   EQ 2GM BASE/VIAL                                                           EQ 10GM BASE/VIAL                                                           (LABELING REVISION --                                                           DOSAGE)50-581     MEFOXIN                 MSD                     CEFOXITIN SODIUM28-FEB-95  IN PLASTIC CONTAINER    WEST POINT, PA          EQ 20MG BASE/ML           (INJECTABLE)            19486                   EQ 40MG BASE/ML                                                           (LABELING REVISION --                                                           DOSAGE)50-662     BIAXIN                  ABBOTT                  CLARITHROMYCIN28-FEB-95  (TABLET)                ABBOTT PARK, IL         250MG                                   60064                   500MG                                                           (LABELING REVISION --                                                          INDICATIONS AND USAGE;                                                           PRECAUTIONS)                    ***BIOLOGICAL PRODUCT LICENSES ISSUED***1180      NONE               CENLA PLASMA               SOURCE PLASMA15-FEB-95 (NONE)             ROUND ROCK, TX             (FOR FURTHER                              78664                      MANUFACTURING USE)                                                        (A,B)1181      NONE               INSTITUTO GRIFOLS S A      ALBUMIN (HUMAN)17-FEB-95 (INJECTABLE)       BARCELONA, SPAIN           (A,B) 1090      HAVRIX             SMITHKLINE BEECHAM         HEPATITIS A VACCINE22-FEB-95 (INJECTABLE)       1330 RIXENSART             (IMMUNIZATION AGAINST                             BELGIUM                    HEPATITIS A)                                                        (B)1177      NONE               MICRO TYPING SYS           BLOOD GROUPING REAGENT24-FEB-95 (IN-VITRO)         POMPANO BEACH, FL          (B)                                     33069(A) Establishment License Issued(B) Product License Issued                   ***BIOLOGICAL PRODUCT DEVICE APPROVALS***BK940040  SEPACELL PLS-4A    BAXTER HLTHCARE            REDUCTION FILTERS FOR14-FEB-95 AND PLS-10A        ROUND LAKE, IL             PLATELET PRODUCTS          LEUKOCYTE          60073                      (C)BK940041  SEPACELL R2000     BAXTER HLTHCARE            LEUKOCYTE REDUCTION14-FEB-95                    ROUND LAKE, IL             SET FOR RED BLOOD CELLS                             60073                      (C)(C) Substantially Equivalent             ***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 PUBLICATIONP920051  STORZ MODULITH        KARL STORZ ENDOSCOPY-   USE IN NONINVASIVE02/17/95 LITHOTRIPTER,         AMERICA, INC.           FRAGMENTATION OF         MODEL SL20            KENNESAW, GA            URINARY CALCULI IN                                 30144                 THE KIDNEY AND UPPER                                                       URETERP930029  ATAKR RADIO           MEDTRONIC CARDIORHYTHM  1)INTERRUPTION OF 02/09/95 FREQUENCY CATHETER    SAN JOSE, CA            ACCESSORY          ABLATION (RFCA)         95134-1806            ATRIOVENTRICULAR (AV)         SYSTEM-RF ABLATR                              CONDUCTION PATHWAYS         & RF MARINR SERIES                            ASSOC W/TACHYCARDIA          OF RFCA CATHETERS                             (TC) 2)TREATMENT OF                                                       AV NODAL REENTRANT TC                                                       3)CREATION OF COMPLETE                                                       AV BLOCK                    ***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 PRIOR TO PUBLICATIONN16895/S83  OPTIMA                BAUSCH & LOMB           LABELING02/23/95    (POLYMACON)           ROCHESTER, NY           MODIFICATIONS            VISIBILITY TINTED       04500            HYDROPHILIC             CONTACT LENSESN17004/S6   SURGICAL              HOWMEDICA, INC.         CHANGES MADE TO02/24/95    SIMPLEX P             RUTHERFORD, NJ          PACKAGE INSERT OF THE                    RADIOPAQUE BONE         07070-2584            DEVICE            CEMENT N180033/S27 ACUVUE                JOHNSON & JOHNSON       ALTERNATE02/13/95    (ETAFILCON A)         VISION PRODUCTS, INC.   MANUFACTURING SITE            SOFT (HYDROPHILIC)    JACKSONVILLE, FL                                            CONTACT LENSES          32247                                            N50510/S57  VITEK SYSTEMS        BIOMERIEUX VITEK, INC.   REMOVAL OF DISCLAIMER  02/23/95    "GENERAL              HAZELWOOD, MO           FOR PSEUDOMONAS/            SUSCEPTIBILITY CARD"    63042-2395            CIPROFLOXACINP810002/S34 ST. JUDE MEDICAL      ST. JUDE MEDICAL, INC.  REMOVAL OF THE02/16/95    MECHANICAL HEART      ST. PAUL, MN            MANUFACTURING CHECK            VALVE                   55117                 SHEET REGARDING THE                                                          ORIENTATION OF THE                                                          VALVE IN THE VALVE                                                          HOLDERP810031/S18 HEALON                PHARMACIA, INC.         CHANGING FROM THE02/17/95    VISCOELASTIC          OPHTHALMICS             RABBIT PYROGEN TEST            PRODUCTS              MONROVIA, CA            TO THE LIMULUS                                    91017-7136            AMOEBOCYTE LYSATE                                                          (LAL) TEST FOR THE                                                          DETECTION OF                                                          BACTERIAL ENDOTOXINP820021/S24 NEWVUES               CIBA VISION CORPORATION NEW MODEL LABELING02/13/95    THERAPEUTIC           DULUTH, GA              MODIFICATIONS            (VIFILCON A)            30136-1518            SOFT (HYDROPHILIC)              CONTACT LENSESP840039/S47 ULTRAVIOLET (UV)      STORZ OPHTHALMICS, INC. USE OF A NEW LENS02/08/95    ABSORBING AND         CLEARWATER, FL          CARRIER            NON-UV ABSORBING        34619            PMAA INTRAOCULAR             LENSES (IOLS)P840040/S47 MEDI-TECH             BOSTON SCIENTIFIC       THE DEVICE AS02/23/95    CORONARY BALLOON      CORPORATION             MODIFIED WILL BE            DILATATION            WATERTOWN, MA           MARKETED UNDER THE            CATHETER -              02172-2414            TRADE NAME:SYNERGY II            SYNERGY II LONG                               CONVERTIBLE RAPID            BALLOON                                       EXCHANGE CATHETER            DILATATION CATHETER  P850036/S2  BAUSCH & LOMB         BAUSCH & LOMB           FORMULATION02/23/95    SENSITIVE EYES        ROCHESTER, NY           ADJUSTMENT TO ENHANCE            LENS LUBRICANT          14692-0450            THE STABILITY AND AN                                                          ALTERNATE 3 ML SIZE                                                          BOTTLEP860002/S16 ULTRAVIOLET (UV)      STORZ OPHTHALMICS, INC. USE OF A NEW LENS02/08/95    ABSORBING AND         CLEARWATER, FL          CARRIER            NON-UV ABSORBING        34619             PMAA INTRAOCULAR              LENSES (IOLS)P860034/S11 MODELS AC-21          ALLERGAN MEDICAL OPTICS REVISED LABELING THAT02/03/95    NON-ULTRAVIOLET-      IRVINE, CA              CONTAINS 3-YEAR DATA            ABSORBING AND AC-21B    92718                 FOR MODELS AC-21 &            ULTRAVIOLET-                                  AC-21B ANTERIOR            ABSORBING                                     CHAMBER INTRAOCULAR            ANTERIOR CHAMBER                              LENSES (IOLS)            INTRAOCULAR LENSESP870036/S31 VERSAFLEX             MEDTRONIC INTERVENTIONAL APPROVAL FOR THE02/15/95    BUCHBINDER            VASCULAR                MEDTRONIC FALCON            OMNIFLEX PTCA         SAN DIEGO, CA           CORONARY BALLOON            CATHETER SYSTEM -       92121-2256            DILATATION CATHETER            MEDTRONIC FALCON            CORONARY BALLOON            DILATATION CATHETERP870073/S16 ULTRAVIOLET (UV)      STORZ OPHTHALMICS, INC. USE OF A NEW LENS02/08/95    ABSORBING AND         CLEARWATER, FL          CARRIER            NON-UV ABSORBING        34619            PMMA INTRAOCULAR            LENSES (IOLS)P880079/S13 PURE EYES             CIBA VISION CORPORATION NAME CHANGE & REVISED02/09/95    CLEANER/RINSE         DULUTH, GA              LABELING FOR SOFTWEAR                                    30136-1518            PLUS SALINE - THE                                                          DEVICE WILL BE                                                          MARKETED UNDER TRADE                                                          NAME:PURE EYES                                                          CLEANER/RINSE                                                                            P880090/S16 ULTRAVIOLET (UV)      STORZ OPHTHALMICS, INC. USE OF A NEW LENS02/08/95    ABSORBING AND         CLEARWATER, FL          CARRIER            NON-UV ABSORBING        34619             PMMA INTRAOCULAR            LENSES (IOLS)P890003/S35 MEDTRONIC MINUET      MEDTRONIC, INC.         APPROVAL TO MARKET02/15/95    PULSE GENERATOR       MINNEAPOLIS, MN         THE REFERENCED MODELS            MODELS 7107 & 7108      55432-3576            OF THE PACEMAKER AS                                                          THE VITATRON LEGACY D                                                                                                                           MODELS 750 & 751P890056/S1  MODEL PC-28LB         ALLERGAN MEDICAL OPTICS CHANGE STERILIZATION02/08/95    ULTRAVIOLET-          SANTA ANA, CA           CYCLE TO 100%            ABSORBING               92799-5155            ETHYLENE OXIDE CYCLE            POSTERIOR CHAMBER                             WITH A NITROGEN PURGE            INTRAOCULAR LENSP900039/S7  COLLAGRAFT BONE       COLLAGEN CORPORATION   PACKAGING MODIFICATIONS02/14/95    GRAFT MATRIX          PALO ALTO, CA                                      94303                                                                                              P900060/S3  CARBOMEDICS           CARBOMEDICS, INC.       APPROVAL TO UTILIZE  02/16/95    PROSTHETIC HEART      AUSTIN, TX              NEW STEAM STERILIZER            VALVE                   78752-1793            AND AN ENLARGED                                                          CONTROLLED                                                          ENVIRONMENT IN THE                                                          AUSTIN MANUFACTURING                                                          FACILITYP910056/S3  CHIROFLEX II          CHIRON VISION           CHANGE IN HAPTIC PULL02/17/95    MULTI-PIECE           CORPORATION             TEST            SILICONE IOLS         IRVINE, CA                                    92718-1903P940013/S1  PRECISION UV          PILKINGTON BARNES HIND  ADDITION OF LIGHT02/09/95    (VASURFILCON)         SUNNYVALE, CA           BLUE LOCATOR TINT & A            SOFT (HYDROPHILIC)      94086-5200            CONTACT LENS            CONTACT LENSES                                STABILITY EXTENSION            FOR EXTENDED WEAR                             PROTOCOL & AN            (CLEAR & TINTED)                              ALTERNATE                                                          MANUFACTURING SITE                        ***ORIGINAL VETERINARY NADAs***           THERE ARE NO ORIGINAL VETERINARY NADAs FOR FEBRUARY 1995.                  ***ORIGINAL ABBREVIATED VETERINARY NADAs***     THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR FEBRUARY 1995.                      ***SUPPLEMENTAL VETERINARY NADAs***091-582   GILT EDGE TYLAN MIX   CATTLE,     PREMIERE AGRI TECH TYLOSIN PHOSPHATE07-FEB-95 (PREMIX)              CHICKENS,   FORT WAYNE, IN          20GM/LB                                SWINE       46801