Drug Approvals for March 2000

Definitions and Notes

Original New Drug Applications

Original Application #: 020789
Approval Date: 27-MAR-00
Trade Name: ZONEGRAN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: DAINIPPON PHARMACEUTICAL USA CORP
Active Ingredient(s): ZONISAMIDE
OTC/RX Status: RX
Indication(s): Provides for the use of Zonegran capsules as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

Original Application #: 021124
Approval Date: 17-MAR-00
Trade Name: LAMISIL
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP
Active Ingredient(s): TERBINAFINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of interdigital-type pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm) due to Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum

Original Application #: 021043
Approval Date: 07-MAR-00
Trade Name: RID MOUSSE
Chemical Type:
Therapeutic Potential: S
Dosage Form: EMULSION, AEROSOL FOAM
Applicant: SOLTEC RESEARCH PTY LTD
Active Ingredient(s): PIPERONYL BUTOXIDE; PYRETHRINS
OTC/RX Status: OTC
Indication(s): For the treatment of head, pubic (crab), and body lice

Original Application #: 050775
Approval Date: 03-MAR-00
Trade Name: BIAXIN XL FILMTAB
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Indication(s): For Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis

Original Application #: 021088
Approval Date: 03-MAR-00
Trade Name: VIADUR
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: IMPLANT
Applicant: ALZA CORP
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX
Indication(s): For the palliative treatment of advanced prostate cancer

Original Application #: 021129
Approval Date: 02-MAR-00
Trade Name: NEURONTIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: PARKE DAVIS PHARMACEUTICALS LTD
Active Ingredient(s): GABAPENTIN
OTC/RX Status: RX
Indication(s): For use as an adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy

Efficacy Supplemental New Drug Applications

Application #: 020402 Efficacy Supplement#: 005
Type: SE1 to Original New Drug Application
Approval Date: 16-MAR-00
Trade Name: ADVIL LIQUI-GELS
Dosage Form: CAPSULE
Applicant: WHITEHALL ROBINS HEALTHCARE
Active Ingredient(s): IBUPROFEN POTASSIUM
OTC/RX Status: OTC
Efficacy Claim: For the treatment of migraine

Application #: 020830 Efficacy Supplement#: 008
Type: SE1 to Original New Drug Application
Approval Date: 03-MAR-00
Trade Name: SINGULAIR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX
Efficacy Claim: For prophylxis of asthma in pediatric 2 to 5 years of age

Approvable Original New Drug Applications

Original Application #: 020748
Approvable Date: 08-MAR-00
Trade Name: DIFFERIN
Dosage Form: CREAM
Applicant: GALDERMA LABORATORIES INC
Active Ingredient(s): ADAPALENE
OTC/RX Status: RX

Original Application #: 021120
Approvable Date: 01-MAR-00
Trade Name: NOVANTRONE
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): MITOXANTRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 040320
Approval Date: 31-MAR-00
Trade Name: METHIMAZOLE
Dosage Form: TABLET
Applicant: APPLIED ANALYTICAL INDUSTRIES INC
Active Ingredient(s): METHIMAZOLE
OTC/RX Status: RX

Original Abbreviated Application # 075358
Approval Date: 29-MAR-00
Trade Name: ALBUTEROL SULFATE
Dosage Form: SOLUTION
Applicant: BAUSCH AND LOMB INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 040350
Approval Date: 29-MAR-00
Trade Name: METHIMAZOLE
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): METHIMAZOLE
OTC/RX Status: RX

Original Abbreviated Application # 075014
Approval Date: 28-MAR-00
Trade Name: PERMETHRIN LOTION
Dosage Form: LOTION
Applicant: ALPHARMA USPD INC
Active Ingredient(s): PERMETHRIN
OTC/RX Status: RX

Original Abbreviated Application # 074699
Approval Date: 24-MAR-00
Trade Name: PENTAZOCINE HCL AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application # 064200
Approval Date: 24-MAR-00
Trade Name: STERILE CEFOTAXIME
Dosage Form: POWDER
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): CEFOTAXIME SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075523
Approval Date: 17-MAR-00
Trade Name: PENTAZOCINE AND NALOXONE HCL
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): PENTAZOCINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075395
Approval Date: 16-MAR-00
Trade Name: ISOSORBIDE MONONITRATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: KV PHARMACEUTICAL CO
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX

Original Abbreviated Application # 074793
Approval Date: 16-MAR-00
Trade Name: LORAZEPAM
Dosage Form: INJECTABLE
Applicant: MOVA PHARMACEUTICALS CORP
Active Ingredient(s): LORAZEPAM
OTC/RX Status: RX

Original Abbreviated Application # 040277
Approval Date: 16-MAR-00
Trade Name: PROPARACAINE HYDROCHLORIDE
Dosage Form: SOLUTION
Applicant: TAYLOR PHARMACAL CO
Active Ingredient(s): PROPARACAINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 073416
Approval Date: 14-MAR-00
Trade Name: EZ-SCRUB
Dosage Form: SPONGE
Applicant: BECTON DICKINSON ACUTECARE
Active Ingredient(s): CHLORHEXIDINE GLUCONATE
OTC/RX Status: RX

Original Abbreviated Application # 075128
Approval Date: 10-MAR-00
Trade Name: NIFEDIPINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ELAN PHARMACEUTICAL RESEARCH CORPORATION
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065031
Approval Date: 10-MAR-00
Trade Name: BLEOMYCIN
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): BLEOMYCIN
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065025
Approval Date: 03-MAR-00
Trade Name: CYCLOSPORINE
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval

Original Abbreviated Application #: 075527
Tentative Approval Date: 31-MAR-00
Trade Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075347
Tentative Approval Date: 23-MAR-00
Trade Name: OMEPRAZOLE
Dosage Form: CAPSULE, DELAYED RELEASE
Applicant: ANDRX PHARMACEUTICALS INC
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX

Original Abbreviated Application #: 075277
Tentative Approval Date: 20-MAR-00
Trade Name: ENALAPRIL MALEATE
Dosage Form: TABLET
Applicant: ESI LEDERLE INC
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Application #: 075650
Tentative Approval Date: 17-MAR-00
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075416
Tentative Approval Date: 17-MAR-00
Trade Name: NAPROXEN SODIUM
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ANDRX PHARMACEUTICALS INC
Active Ingredient(s): NAPROXEN SODIUM
OTC/RX Status: RX

Original Abbreviated Application #: 075628
Tentative Approval Date: 16-MAR-00
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application # 075560
Approval Date: 15-MAR-00
Trade Name: CIMETIDINE HCL
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075409
Tentative Approval Date: 15-MAR-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075517
Approval Date: 14-MAR-00
Trade Name: URSODIOL
Dosage Form: CAPSULE
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): URSODIOL
OTC/RX Status: RX

Original Abbreviated Application # 075128
Approval Date: 10-MAR-00
Trade Name: NIFEDIPINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ELAN PHARMACEUTICAL RESEARCH CORP
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Original Abbreviated Application # 075434
Approval Date: 08-MAR-00
Trade Name: NALTREXONE HCL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): NALTREXONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075579
Tentative Approval Date: 02-MAR-00
Trade Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 021004 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 31-MAR-00
Trade Name: EPIVIR-HBV
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 021003 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 31-MAR-00
Trade Name: EPIVIR-HBV
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 010251 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 31-MAR-00
Trade Name: INVERSINE
Dosage Form: TABLET
Applicant: LAYTON BIOSCIENCE INC
Active Ingredient(s): MECAMYLAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020779 Labeling Supplement #: 029
To Original New Drug Application
Approval Date: 28-MAR-00
Trade Name: VIRACEPT
Dosage Form: TABLET
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX

Application #: 020778 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 28-MAR-00
Trade Name: VIRACEPT
Dosage Form: POWDER
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX

Application #: 017516 Labeling Supplement#: 017
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: SINEQUAN
Dosage Form: CONCENTRATE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXEPIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017516 Labeling Supplement#: 016
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: SINEQUAN
Dosage Form: CONCENTRATE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXEPIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017516 Labeling Supplement#: 013
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: SINEQUAN
Dosage Form: CONCENTRATE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXEPIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017516 Labeling Supplement#: 012
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: SINEQUAN
Dosage Form: CONCENTRATE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXEPIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016798 Labeling Supplement#: 046
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: SINEQUAN
Dosage Form: CAPSULE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXEPIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016798 Labeling Supplement#: 045
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: SINEQUAN
Dosage Form: CAPSULE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXEPIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016798 Labeling Supplement#: 042
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: SINEQUAN
Dosage Form: CAPSULE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXEPIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016798 Labeling Supplement#: 041
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: SINEQUAN
Dosage Form: CAPSULE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXEPIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016798 Labeling Supplement#: 037
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: SINEQUAN
Dosage Form: CAPSULE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXEPIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 011909 Labeling Supplement#: 029
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: NARDIL
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): PHENELZINE SULFATE
OTC/RX Status: RX

Application #: 011909 Labeling Supplement#: 026
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: NARDIL
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): PHENELZINE SULFATE
OTC/RX Status: RX

Application #: 011909 Labeling Supplement#: 025
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: NARDIL
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): PHENELZINE SULFATE
OTC/RX Status: RX

Application #: 011909 Labeling Supplement#: 024
To Original New Drug Application
Permitted Date: 28-MAR-00
Trade Name: NARDIL
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): PHENELZINE SULFATE
OTC/RX Status: RX

Application #: 017362 Labeling Supplement #: 089
To Original New Drug Application
Approval Date: 27-MAR-00
Trade Name: PROGESTERONE INJECTION
Dosage Form: INJECTABLE
Applicant: SCHEIN PHARMACEUTICALS
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX

Application #: 020896 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 24-MAR-00
Trade Name: XELODA
Dosage Form: TABLET
Applicant: HOFFMAN LA ROCHE INC
Active Ingredient(s): CAPECITABINE
OTC/RX Status: RX

Application #: 020401 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 24-MAR-00
Trade Name: TIAZAC
Dosage Form: CAPSULE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019192 Labeling Supplement #: 035
To Original New Drug Application
Approval Date: 23-MAR-00
Trade Name: TRIPHASIL-21
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): LEVONORGESTREL; ETHINYL ESTRADIOL; LEVONORGESTR EL; ETHINYL ESTRADIOL; LEVONORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 019190 Labeling Supplement #: 036
To Original New Drug Application
Approval Date: 23-MAR-00
Trade Name: TRIPHASIL-28
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): LEVONORGESTREL; ETHINYL ESTRADIOL; LEVONORGESTR EL; ETHINYL ESTRADIOL; LEVONORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 018571 Labeling Supplement #: 015
To Original New Drug Application
Approval Date: 21-MAR-00
Trade Name: BRETHINE
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): TERBUTALINE SULFATE
OTC/RX Status: RX

Application #: 019758 Labeling Supplement #: 041
To Original New Drug Application
Approval Date: 17-MAR-00
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX

Application #: 009386 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 15-MAR-00
Trade Name: MYLERAN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BUSULFAN
OTC/RX Status: RX

Application #: 020899 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 14-MAR-00
Trade Name: OPTISON
Dosage Form: INJECTABLE
Applicant: MOLECULAR BIOSYSTEMS INC
Active Ingredient(s): ALBUMIN HUMAN
OTC/RX Status: RX

Application #: 019787 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 14-MAR-00
Trade Name: NORVASC
Dosage Form: TABLET
Applicant: PFIZER AGRICULTURAL DIV
Active Ingredient(s): AMLODIPINE BESYLATE
OTC/RX Status: RX

Application #: 016812 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 14-MAR-00
Trade Name: KETALAR
Dosage Form: INJECTABLE
Applicant: PARKEDALE PHARMACEUTICALS INC
Active Ingredient(s): KETAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020992 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 13-MAR-00
Trade Name: CENESTIN
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): CONJUGATED ESTROGENS A
OTC/RX Status: RX

Application #: 020333 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 13-MAR-00
Trade Name: AGRYLIN
Dosage Form: CAPSULE
Applicant: ROBERTS LABORATORIES INC
Active Ingredient(s): ANAGRELIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019596 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 10-MAR-00
Trade Name: MAGNEVIST
Dosage Form: INJECTABLE
Applicant: BERLEX LABORATORIES INC SUB SCHERING AG
Active Ingredient(s): GADOPENTETATE DIMEGLUMINE
OTC/RX Status: RX

Application #: 021066 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 08-MAR-00
Trade Name: ZADITOR
Dosage Form: SOLUTION
Applicant: CIBA VISION
Active Ingredient(s): KETOTIFEN FUMARATE
OTC/RX Status: RX

Application #: 020055 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 08-MAR-00
Trade Name: MICRONIZED GLYBURIDE
Dosage Form: TABLET
Applicant: AVENTIS PHARMACEUTICALS
Active Ingredient(s): MICRONIZED GLYBURIDE
OTC/RX Status: RX

Application #: 020767 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 06-MAR-00
Trade Name: PROPULSID QUICKSOLV
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): CISAPRIDE
OTC/RX Status: RX

Application #: 20398 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 06-MAR-00
Trade Name: PROPULSID
Dosage Form: SUSPENSION
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): CISAPRIDE
OTC/RX Status: RX

Application #: 020210 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 06-MAR-00
Trade Name: PROPULSID
Dosage Form: TABLET
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): CISAPRIDE
OTC/RX Status: RX

Application #: 016367 Labeling Supplement#: 170
To Original New Drug Application
Approval Date: 06-MAR-00
Trade Name: DEXTROSE 5% IN FLEXIBLE CONTAINERS
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE
OTC/RX Status: RX

Application #: 020507 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 03-MAR-00
Trade Name: TECZEM
Dosage Form: TABLET
Applicant:MERCK RESEARCH LABATORIES
Active Ingredient(s): ENALAPRIL MALEATE; DILTIAZEM MALATE
OTC/RX Status: RX

Application #: 019463 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 02-MAR-00
Trade Name: TIMOPTIC IN OCUDOSE
Dosage Form: SOLUTION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 019463 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 02-MAR-00
Trade Name: TIMOPTIC IN OCUDOSE
Dosage Form: SOLUTION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 020818 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 01-MAR-00
Trade Name: DIOVAN HCT
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): VALSARTAN; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX