Drug Approvals for July 1997
Definitions and Notes
July 1997
Original New Drug Applications
Original Application #: 020701
Approval Date: 31-JUL-97
Trade Name: CRINONE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GEL
Applicant: COLUMBIA RESEARCH LABORATORIES INC
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX
Indication(s): Treatment of secondary amenorrhea
Original Application #: 020648
Approval Date: 29-JUL-97
Trade Name: DIASTAT
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GEL
Applicant: ATHENA NEUROSCIENCES INC
Active Ingredient(s): DIAZEPAM
OTC/RX Status: RX
Indication(s): Management of selected, refractory, epileptic patients, on stable regimens of antiepileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizure frequency
Original Application #: 020381
Approval Date: 28-JUL-97
Trade Name: NIASPAN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: KOS PHARMACEUTICALS INC
Active Ingredient(s): NIACIN
OTC/RX Status: RX
Indication(s): 1)As an adjunct to diet for reduction of elevated total cholesterol, LDL cholesterol, ApoB, and triglyceride levels in adult patients with primary hypercholesterolemia and mixed dyslipidemia (Types IIa and IIb);2) in combination with a bile-acid binding resin as an adjunct to diet for reduction of elevated total and LDL cholesterol levels in adult patients with primary hypercholesterolemia (Type IIa);3) as adjunctive therapy for treatment of adult patients with very high serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them; 4)in patients with history of myocardial infarction and hypercholesterolemia, to reduce the risk of recurrent nonfatal myocardial infarction and;5) in patients with a history of coronary artery disease (CAD) and hypercholesterolemia, in combination with a bile acid binding resin, to slow progression or promote regression of atherosclerotic disease
Original Application #: 020726
Approval Date: 25-JUL-97
Trade Name: FEMARA
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): LETROZOLE
OTC/RX Status: RX
Indication(s): For treatment of advanced breast cancer in postmenopausal women
Original Application #: 020448
Approval Date: 24-JUL-97
Trade Name: IMODIUM A-D
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, CHEWABLE
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE
OTC/RX Status: OTC
Indication(s): Control of the symptoms of diarrhea including Traveler's diarrhea
Original Application #: 020519
Approval Date: 21-JUL-97
Trade Name: LOPROX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GEL
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): CICLOPIROX
OTC/RX Status: RX
Indication(s): Topical treatment of interdigital tinea pedis, tinea cruris and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum, and for the topical treatment of seborrheic dermatitis of the scalp
Original Application #: 020535
Approval Date: 15-JUL-97
Trade Name: DURACT
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): BROMFENAC SODIUM
OTC/RX Status: RX
Indication(s): Indicated for the short-term (generally less than 10 days) management of pain
Original Application #: 020231
Approval Date: 11-JUL-97
Trade Name: TOTAL TOOTHPASTE
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: DENTIFRICE
Applicant: COLGATE PALMOLIVE CO
Active Ingredient(s): SODIUM FLUORIDE; TRICLOSAN
OTC/RX Status: OTC
Indication(s): Aids in the prevention of cavities, plaque, and gingivitis
Original Application #: 020667
Approval Date: 01-JUL-97
Trade Name: MIRAPEX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): PRAMIPEXOLE DIHYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of the signs and symptoms of idiopathic Parkinsons Disease
Efficacy Supplemental New Drug Applications
Application #: 020220 Efficacy Supplement#: 002
Type: SE5 to Original New Drug Application
Approval Date: 23-JUL-97
Trade Name: ULTRAVIST 370
Dosage Form: INJECTABLE
Applicant: BERLEX LABORATORIES INC SUB SCHERING AG
Active Ingredient(s): IOPROMIDE
OTC/RX Status: RX
Efficacy Claim: For the use in the pediatric population over 2 years of age
Application #: 019839 EfficacySupplement #: 011
Type: SE1 to Original New Drug Application
Approval Date: 08-JUL-97
Trade Name: ZOLOFT
Dosage Form: TABLET
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Treatment of panic disorder in a recommended dose range of 50 to 200mg/day
Application #: 020528 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 02-JUL-97
Trade Name: MAVIK
Dosage Form: TABLET
Applicant: KNOLL PHARMACEUTICAL CO SUB BASF CORP
Active Ingredient(s): TRANDOLAPRIL
OTC/RX Status: RX
Efficacy Claim: Treatment of patients with post myocardial infarction left ventricular dysfunction or post myocardial infarction heart failure
Approvable Original New Drug Applications
Original Application #: 020639
Approvable Date: 28-JUL-97
Trade Name: SEROQUEL
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): QUETIAPINE FUMARATE
OTC/RX Status: RX
Original Application #: 020378
Approvable Date: 16-JUL-97
Trade Name: GONAL-F
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): FOLLITROPIN ALFA
OTC/RX Status: RX
Original Application #: 020745
Approvable Date: 08-JUL-97
Trade Name: ZANTAC 75
Dosage Form: TABLET, EFFERVESCENT
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: OTC
Original Abbreviated New Drug Applications
Original Abbreviated Application # 074488
Approval Date: 31-JUL-97
Trade Name: RANITIDINE HCL
Dosage Form: TABLET
Applicant: GRANUTEC PHARMACEUTICALS INC SUB GRANUTEC INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074499
Approval Date: 30-JUL-97
Trade Name: ATENOLOL
Dosage Form: TABLET
Applicant: MUTUAL PHARMACEUTICAL CO INC
Active Ingredient(s): ATENOLOL
OTC/RX Status: RX
Original Abbreviated Application # 074935
Approval Date: 29-JUL-97
Trade Name: FLUOCINONIDE
Dosage Form: GEL
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): FLUOCINONIDE
OTC/RX Status: RX
Original Abbreviated Application # 081118
Approval Date: 21-JUL-97
Trade Name: ISONIAZID
Dosage Form: SYRUP
Applicant: MIKART INC
Active Ingredient(s): ISONIAZID
OTC/RX Status: RX
Original Abbreviated Application # 074901
Approval Date: 18-JUL-97
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX
Original Abbreviated Application # 074900
Approval Date: 18-JUL-97
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX
Original Abbreviated Application # 074586
Approval Date: 17-JUL-97
Trade Name: M-ZOLE 7 DUAL PACK
Dosage Form: CREAM; SUPPOSITORY
Applicant: ALPHARMA USPD INC
Active Ingredient(s): MICONAZOLE NITRATE
OTC/RX Status: OTC
Original Abbreviated Application # 074842
Approval Date: 17-JUL-97
Trade Name: ETODOLAC
Dosage Form: CAPSULE
Applicant: ENDO LABORATORIES INC DIV DUPONT MERCK PHARMACEUTICAL CO
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX
Original Abbreviated Application # 074400
Approval Date: 17-JUL-97
Trade Name: DIFLUNISAL
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): DIFLUNISAL
OTC/RX Status: RX
Original Abbreviated Application # 074101
Approval Date: 17-JUL-97
Trade Name: ATENOLOL
Dosage Form: TABLET
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): ATENOLOL
OTC/RX Status: RX
Original Abbreviated Application # 040011
Approval Date: 17-JUL-97
Trade Name: METHAZOLAMIDE
Dosage Form: TABLET
Applicant: APPLIED ANALYTICAL INDUSTRIES
Active Ingredient(s): METHAZOLAMIDE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 063304
Approval Date: 15-JUL-97
Trade Name: CLINDAMYCIN PHOSPHATE
Dosage Form: SOLUTION
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX
Original Abbreviated Application # 074839
Approval Date: 11-JUL-97
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX
Original Abbreviated Application # 074921
Approval Date: 10-JUL-97
Trade Name: ESTAZOLAM
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): ESTAZOLAM
OTC/RX Status: RX
Original Abbreviated Application # 074967
Approval Date: 09-JUL-97
Trade Name: NITROFURANTOIN
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): NITROFURANTOIN, MACROCRYSTALLINE
OTC/RX Status: RX
Original Abbreviated Application # 074878
Approval Date: 09-JUL-97
Trade Name: PENTOXIFYLLINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): PENTOXIFYLLINE
OTC/RX Status: RX
Original Abbreviated Application # 074813
Approval Date: 09-JUL-97
Trade Name: ETOPOSIDE
Dosage Form: INJECTABLE
Applicant: PIERRE FABRE MEDICAMENT
Active Ingredient(s): ETOPOSIDE
OTC/RX Status: RX
Original Abbreviated Application # 074771
Approval Date: 09-JUL-97
Trade Name: CHOLESTYRAMINE
Dosage Form: SUSPENSION
Applicant: BAKER NORTON
Active Ingredient(s): CHOLESTYRAMINE
OTC/RX Status: RX
Original Abbreviated Application # 074899
Approval Date: 08-JUL-97
Trade Name: ETODOLAC
Dosage Form: CAPSULE
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX
Original Abbreviated Application # 074877
Approval Date: 08-JUL-97
Trade Name: PENTOXIFYLLINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ESI LEDERLE INC
Active Ingredient(s): PENTOXIFYLLINE
OTC/RX Status: RX
Original Abbreviated Application # 074808
Approval Date: 08-JUL-97
Trade Name: PIROXICAM
Dosage Form: CAPSULE
Applicant: AEGIS PHARMACEUTICALS
Active Ingredient(s): PIROXICAM
OTC/RX Status: RX
Original Abbreviated Application # 074425
Approval Date: 08-JUL-97
Trade Name: PENTOXIFYLLINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): PENTOXIFYLLINE
OTC/RX Status: RX
Original Abbreviated Application # 040209
Approval Date: 07-JUL-97
Trade Name: TRIFLUOPERAZINE HCL
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): TRIFLUOPERAZINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074826
Approval Date: 03-JUL-97
Trade Name: ESTAZOLAM
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): ESTAZOLAM
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Approvals with Tentative Approval
Original Abbreviated Application #: 074735
Tentative Approval Date: 29-JUL-97
Trade Name: CISPLATIN
Dosage Form: INJECTABLE
Applicant: FUJISAWA USA
Active Ingredient(s): CISPLATIN
OTC/RX Status: RX
Original Abbreviated Application #: 074864
Tentative Approval Date: 24-JUL-97
Trade Name: RANITIDINE HCL
Dosage Form: TABLET
Applicant: CHELSEA LABORATORIES
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 074777
Tentative Approval Date: 24-JUL-97
Trade Name: RANITIDINE HCL
Dosage Form: INJECTABLE
Applicant: BEN VENUE LABORATORIES INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 074764
Tentative Approval Date: 24-JUL-97
Trade Name: RANITIDINE HCL
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 074655
Tentative Approval Date: 24-JUL-97
Trade Name: RANITIDINE HCL
Dosage Form: CAPSULE
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 074827
Tentative Approval Date: 21-JUL-97
Trade Name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Original Abbreviated Application #: 074651
Tentative Approval Date: 16-JUL-97
Trade Name: TERAZOSIN HCL
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 050718 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 31-JUL-97
Trade Name: DOXIL
Dosage Form: INJECTABLE
Applicant: SEQUUS PHARMACEUTICALS INC
Active Ingredient(s): DOXORUBICIN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020779 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 31-JUL-97
Trade Name: VIRACEPT
Dosage Form: TABLET
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX
Application #: 020778 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 31-JUL-97
Trade Name: VIRACEPT
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX
Application #: 020527 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 31-JUL-97
Trade Name: PREMPRO/PREMPHASE
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE;
OTC/RX Status: RX
Application #: 012151 Labeling Supplement#: 056
To Original New Drug Application
Approval Date: 30-JUL-97
Trade Name: ALDACTONE
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): SPIRONOLACTONE
OTC/RX Status: RX
Application #: 012151 Labeling Supplement#: 035
To Original New Drug Application
Approval Date: 30-JUL-97
Trade Name: ALDACTONE
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): SPIRONOLACTONE
OTC/RX Status: RX
Application #: 050425 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 29-JUL-97
Trade Name: GARAMYCIN
Dosage Form: OINTMENT
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): GENTAMICIN SULFATE
OTC/RX Status: RX
Application #: 050039 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 29-JUL-97
Trade Name: GARAMYCIN OPHTHALMIC OINTMENT
Dosage Form: SOLUTION/DROPS
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): GENTAMICIN SULFATE
OTC/RX Status: RX
Application #: 020616 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 29-JUL-97
Trade Name: KADIAN
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: FAULDING SERVICES INC
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX
Application #:019668 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 29-JUL-97
Trade Name: CARDURA
Dosage Form: TABLET
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX
Application #: 019614 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 29-JUL-97
Trade Name: VERELAN
Dosage Form: CAPSULE
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018261 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 29-JUL-97
Trade Name: PITOCIN
Dosage Form: INJECTABLE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): OXYTOCIN
OTC/RX Status: RX
Application #: 012770 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 29-JUL-97
Trade Name: VOSOL HC
Dosage Form: SOLUTION/DROPS
Applicant: WALLACE LABORATORIES DIV CARTER WALLACE INC
Active Ingredient(s): ACETIC ACID, GLACIAL; HYDROCORTISONE
OTC/RX Status: RX
Application #: 012179 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 29-JUL-97
Trade Name: VOSOL
Dosage Form: SOLUTION/DROPS
Applicant: WALLACE LABORATORIES DIV CARTER WALLACE INC
Active Ingredient(s): ACETIC ACID, GLACIAL
OTC/RX Status: RX
Application #: 019964 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 28-JUL-97
Trade Name: TERAZOL 3
Dosage Form: CREAM
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): TERCONAZOLE
OTC/RX Status: RX
Application #: 019641 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 28-JUL-97
Trade Name: TERAZOL 3
Dosage Form: SUPPOSITORY
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): TERCONAZOLE
OTC/RX Status: RX
Application #: 019579 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 28-JUL-97
Trade Name: TERAZOL 7
Dosage Form: CREAM
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): TERCONAZOLE
OTC/RX Status: RX
Application #:020208 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 28-JUL-97
Trade Name: METROGEL-VAGINAL
Dosage Form: GEL
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): METRONIDAZOLE
OTC/RX Status: RX
Application #:09402 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 28-JUL-97
Trade Name: DELESTROGEN
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): ESTRADIOL VALERATE
OTC/RX Status: RX
Application #:020604 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 25-JUL-97
Trade Name: SEROSTIM
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SOMATROPIN
OTC/RX Status: RX
Application #: 020553 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 25-JUL-97
Trade Name: OXYCONTIN
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PURDUE PHARMA LP
Active Ingredient(s): OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 011522 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 25-JUL-97
Trade Name: ADDERALL 10; ADDERALL 20
Dosage Form: TABLET
Applicant: RICHWOOD PHARMACEUTICAL CO INC
Active Ingredient(s): AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
OTC/RX Status: RX
Application #: 020014 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 24-JUL-97
Trade Name: MAXAIR
Dosage Form: AEROSOL, METERED
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): PIRBUTEROL ACETATE
OTC/RX Status: RX
Application #: 005010 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 24-JUL-97
Trade Name: DEMEROL
Dosage Form: INJECTABLE; SYRUP; TABLET
Applicant: SANOFI WINTHROP INC
Active Ingredient(s): MEPERIDINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018887 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 23-JUL-97
Trade Name: INTAL
Dosage Form: AEROSOL, METERED
Applicant: RHONE POULENC RORER CENTRAL RESEARCH
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: RX
Application #: 018587 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 23-JUL-97
Trade Name: WYTENSIN
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): GUANABENZ ACETATE
OTC/RX Status: RX
Application #: 020184 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 21-JUL-97
Trade Name: ACEON
Dosage Form: TABLET
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): PERINDOPRIL ERBUMINE
OTC/RX Status: RX
Application #:008107 Labeling Supplement#: 051
To Original New Drug Application
Approval Date: 21-JUL-97
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX
Application #: 050639 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 17-JUL-97
Trade Name: CLEOCIN PHOSPHATE IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX
Application #: 050441 Labeling Supplement#: 043
To Original New Drug Application
Approval Date: 17-JUL-97
Trade Name: CLEOCIN PHOSPHATE
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX
Application #: 050162 Labeling Supplement#: 079
To Original New Drug Application
Approval Date: 17-JUL-97
Trade Name: CLEOCIN HCL
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CLINDAMYCIN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019813 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 17-JUL-97
Trade Name: DURAGESIC
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: ALZA CORP
Active Ingredient(s): FENTANYL
OTC/RX Status: RX
Application #:019813 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 17-JUL-97
Trade Name: DURAGESIC
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: ALZA CORP
Active Ingredient(s): FENTANYL
OTC/RX Status: RX
Application #: 019813 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 17-JUL-97
Trade Name: DURAGESIC
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: ALZA CORP
Active Ingredient(s): FENTANYL
OTC/RX Status: RX
Application #: 019813 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 17-JUL-97
Trade Name: DURAGESIC
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: ALZA CORP
Active Ingredient(s): FENTANYL
OTC/RX Status: RX
Application #: 011522 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 17-JUL-97
Trade Name: ADDERALL 10; ADDERALL 20
Dosage Form: TABLET
Applicant: RICHWOOD PHARMACEUTICAL CO INC
Active Ingredient(s): AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
OTC/RX Status: RX
Application #: 011522 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 17-JUL-97
Trade Name: ADDERALL 10; ADDERALL 20
Dosage Form: TABLET
Applicant: RICHWOOD PHARMACEUTICAL CO INC
Active Ingredient(s): AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
OTC/RX Status: RX
Application #: 020563 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 16-JUL-97
Trade Name: HUMALOG
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN LISPRO
OTC/RX Status: RX
Application #: 020064 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 16-JUL-97
Trade Name: MACROBID
Dosage Form: CAPSULE
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN, MACROCRYSTALLINE; NITROFURANTOIN
OTC/RX Status: RX
Application #: 016620 Labeling Supplement#: 062
To Original New Drug Application
Approval Date: 16-JUL-97
Trade Name: MACRODANTIN
Dosage Form: CAPSULE
Applicant: PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN, MACROCRYSTALLINE
OTC/RX Status: RX
Application #: 016402 Labeling Supplement#: 035
To Original New Drug Application
Approval Date: 16-JUL-97
Trade Name: ALUPENT
Dosage Form: AEROSOL, METERED
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): METAPROTERENOL SULFATE
OTC/RX Status: RX
Application #: 008693 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 16-JUL-97
Trade Name: FURADANTIN
Dosage Form: TABLET
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN
OTC/RX Status: RX
Application #: 020363 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 15-JUL-97
Trade Name: FAMVIR
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS CO
Active Ingredient(s): FAMCICLOVIR
OTC/RX Status: RX
Application #: 019670 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 14-JUL-97
Trade Name: CLARITIN-D
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): LORATADINE; PSEUDOEPHEDRINE SULFATE
OTC/RX Status: RX
Application #: 017808 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 14-JUL-97
Trade Name: MIACALCIN
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CALCITONIN, SALMON
OTC/RX Status: RX
Application #: 020547 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 10-JUL-97
Trade Name: ACCOLATE
Dosage Form: TABLET
Applicant: ZENECA LTD
Active Ingredient(s): ZAFIRLUKAST
OTC/RX Status: RX
Application #: 018029 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 09-JUL-97
Trade Name: RITALIN-SR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018029 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 09-JUL-97
Trade Name: RITALIN-SR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018029 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 09-JUL-97
Trade Name: RITALIN-SR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018029 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 09-JUL-97
Trade Name: RITALIN-SR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 017078 Labeling Supplemen#: 027
To Original New Drug Application
Approval Date: 09-JUL-97
Trade Name: DEXEDRINE
Dosage Form: CAPSULE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): DEXTROAMPHETAMINE SULFATE
OTC/RX Status: RX
Application #: 010187 Labeling Supplement#: 048
To Original New Drug Application
Approval Date: 09-JUL-97
Trade Name: RITALIN
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 010187 Labeling Supplement#: 046
To Original New Drug Application
Approval Date: 09-JUL-97
Trade Name: RITALIN
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 010187 Labeling Supplement#: 042
To Original New Drug Application
Approval Date: 09-JUL-97
Trade Name: RITALIN
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 010187 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 09-JUL-97
Trade Name: RITALIN
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 012836 Labeling Supplement #: 051
To Original New Drug Application
Approval Date: 03-JUL-97
Trade Name: PERSANTINE
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): DIPYRIDAMOLE
OTC/RX Status: RX
