Drug Approvals for July 1999

Definitions and Notes

Original New Drug Applications

Original Application #: 021057
Approval Date: 29-JUL-99
Trade Name: ANTAGON
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: ORGANON INC
Active Ingredient(s): GANIRELIX ACETATE
OTC/RX Status: RX
Indication(s): Provides for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation

Original Application #: 021045
Approval Date: 28-JUL-99
Trade Name: PLAN B
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: WOMENS CAPITAL CORP
Active Ingredient(s): LEVONORGESTREL
OTC/RX Status: RX
Indication(s): For emergency contraception

Original Application #: 021036
Approval Date: 26-JUL-99
Trade Name: RELENZA
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INHALANT
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZANAMIVIR
OTC/RX Status: RX
Indication(s): For treatment of uncomplicated acute illness due to influenza virus in adults and adolescents twelve years and older who have been symptomatic for no more than two days

Original Application #: 020988
Approvable Date: 20-JUL-99
Trade Name: PROTONIX
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): PANTOPRAZOLE SODIUM SESQUIHYDRATE
OTC/RX Status: RX

Original Application #: 020951
Approval Date: 09-JUL-99
Trade Name: TAGAMET HB 200
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION
Applicant: SMITHKLINE BEECHAM CONSUMER HEALTHCARE
Active Ingredient(s): CIMETIDINE
OTC/RX Status: OTC
Indication(s): For relief of heartburn associated with acid indigestion and sour stomach and for prevention of heartburn associated with acid indigestion and sour stomach brough on by eating or drinking certain food and beverages

Original Application #: 021066
Approval Date: 02-JUL-99
Trade Name: ZADITOR
Chemical Type:
Therapeutic Potential:
Dosage Form: SOLUTION
Applicant: CIBA VISION
Active Ingredient(s): KETOTIFEN FUMARATE
OTC/RX Status: RX
Indication(s): For the prevention of itching of the eye due to allergic conjunctivitis

Efficacy Supplemental New Drug Applications

Application #:020846 Efficacy Supplement#:001
Type: SE1 to Original New Drug Application
Approval Date: 26-JUL-99
Trade Name: LAMISIL
Dosage Form: GEL
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): TERBINAFINE
OTC/RX Status: RX
Efficacy Claim: Provides for the use of Lamisil DermGel for tinea cruris

Application #:020273 Efficacy Supplement#:004
Type: SE8 to Original New Drug Application
Approval Date: 07-JUL-99
Trade Name: DOVONEX
Dosage Form: OINTMENT
Applicant: WESTWOOD SQUIBB PHARMACEUTICALS INC
Active Ingredient(s): CALCIPOTRIENE
OTC/RX Status: RX
Efficacy Claim: For treatment of plaque psoriasis in adults

Approvable Original New Drug Applications

Original Application #: 020960
Approvable Date: 29-JUL-99
Trade Name: VESTRA
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): REBOXETINE MESYLATE
OTC/RX Status: RX

Original Application #: 020872
Approvable Date: 16-JUL-99
Trade Name: ALLEGRA
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): FEXOFENADINE HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 021043
Approvable Date: 08-JUL-99
Trade Name: RID MOUSSE
Dosage Form: EMULSION, AEROSOL FOAM
Applicant: SOLTEC RESEARCH PTY LTD
Active Ingredient(s): PYRETHRINS; PIPERONYL BUTOXIDE
OTC/RX Status: OTC

Original Application #: 020983
Approvable Date: 01-JUL-99
Trade Name: VENTOLIN HFA
Dosage Form: SOLUTION
Applicant: GLAXO INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075357
Approval Date: 30-JUL-99
Trade Name: MINOXIDIL (FOR MEN)
Dosage Form: SOLUTION
Applicant: PERRIGO CO
Active Ingredient(s): MINOXIDIL
OTC/RX Status: OTC

Original Abbreviated Application # 075357
Approval Date: 30-JUL-99
Trade Name: MINOXIDIL (FOR WOMEN)
Dosage Form: SOLUTION
Applicant: PERRIGO CO
Active Ingredient(s): MINOXIDIL
OTC/RX Status: OTC

Original Abbreviated Application # 075425
Approval Date: 29-JUL-99
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): CIMETIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 075215
Approval Date: 29-JUL-99
Trade Name: LABETALOL HCL
Dosage Form: TABLET
Applicant: MUTUAL PHARMACEUTICAL CO INC
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074432
Approval Date: 29-JUL-99
Trade Name: DICLOFENAC SODIUM
Dosage Form: TABLET, DELAYED RELEASE
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 040353
Approval Date: 29-JUL-99
Trade Name: SPIRONOLACTONE
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): SPIRONOLACTONE
OTC/RX Status: RX

Original Abbreviated Application # 040259
Approval Date: 29-JUL-99
Trade Name: HYDROCORTISONE ACETATE
Dosage Form: CREAM
Applicant: FERNDALE LABORATORIES INC
Active Ingredient(s): HYDROCORTISONE ACETATE
OTC/RX Status: RX

Original Abbreviated Application # 075288
Approval Date: 28-JUL-99
Trade Name: LOW-OGESTREL-21
Dosage Form: TABLET
Applicant: SCS PHARMACEUTICALS
Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 075288
Approval Date: 28-JUL-99
Trade Name: LOW-OGESTREL-28
Dosage Form: TABLET
Applicant: SCS PHARMACEUTICALS
Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 075341
Approval Date: 27-JUL-99
Trade Name: KETOCONAZOLE
Dosage Form: TABLET
Applicant: AESGEN INC
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX

Original Abbreviated Application # 075463
Approval Date: 26-JUL-99
Trade Name: DICLOFENAC POTASSIUM
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): DICLOFENAC POTASSIUM
OTC/RX Status: RX

Original Abbreviated Application # 075114
Approval Date: 26-JUL-99
Trade Name: ACYCLOVIR
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 040341
Approval Date: 26-JUL-99
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040247
Approval Date: 23-JUL-99
Trade Name: HYDROCORTISONE
Dosage Form: LOTION
Applicant: THAMES PHARMACAL CO INC
Active Ingredient(s): HYDROCORTISONE
OTC/RX Status: RX

Original Abbreviated Application # 075067
Approval Date: 19-JUL-99
Trade Name: CROMOLYN SODIUM
Dosage Form: CAPSULE
Applicant: ALPHARMA USPD INC
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 040285
Approval Date: 19-JUL-99
Trade Name: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Dosage Form: SYRUP
Applicant: HALSEY DRUG CO INC
Active Ingredient(s): HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
OTC/RX Status: RX

Original Abbreviated Application # 074735
Approval Date: 16-JUL-99
Trade Name: CISPLATIN
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): CISPLATIN
OTC/RX Status: RX

Original Abbreviated Application # 040301
Approval Date: 15-JUL-99
Trade Name: WARFARIN SODIUM
Dosage Form: TABLET
Applicant: TARO PHARMACEUTICAL INDUSTRIES LTD
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075089
Approval Date: 01-JUL-99
Trade Name: TICLOPIDINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: APOTEX CORPORATION
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075366
Tentative Approval Date: 26-JUL-99
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075518
Tentative Approval Date: 22-JUL-99
Trade Name: MINOXIDIL(FOR MEN)
Dosage Form: SOLUTION
Applicant: ALPHARMA USPD INC
Active Ingredient(s): MINOXIDIL
OTC/RX Status: OTC

Original Abbreviated Application #: 075429
Tentative Approval Date: 20-JUL-99
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #:050662 Labeling Supplement#:026 To Original New Drug Application
Approval Date: 29-JUL-99
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX

Application #:050614 Labeling Supplement#: 019 To Original New Drug Application
Approval Date: 29-JUL-99
Trade Name: KEFTAB
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEPHALEXIN HYDROCHLORIDE
OTC/RX Status: RX

Application #:050614 Labeling Supplement#:018 To Original New Drug Application
Approval Date: 29-JUL-99
Trade Name: KEFTAB
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEPHALEXIN HYDROCHLORIDE
OTC/RX Status: RX

Application #:050614 Labeling Supplement#: 016  To Original New Drug Application
Approval Date: 29-JUL-99
Trade Name: KEFTAB
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEPHALEXIN HYDROCHLORIDE
OTC/RX Status: RX

Application #:050461Labeling Supplement#:133 To Original New Drug Application
Approval Date: 29-JUL-99
Trade Name: ANCEF
Dosage Form: INJECTABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): CEFAZOLIN SODIUM
OTC/RX Status: RX

Application #: 019979 Labeling Supplement#: 017 To Original New Drug Application
Approval Date: 28-JUL-99
Trade Name: TICLID
Dosage Form: TABLET
Applicant: SYNTEX (USA) INC
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 013402 Labeling Supplement#: 081 To Original New Drug Application
Approval Date: 23-JUL-99
Trade Name: ALDORIL
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): METHYLDOPA; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020718 Labeling Supplement#: 003 To Original New Drug Application
Approval Date: 21-JUL-99
Trade Name: INTEGRILIN
Dosage Form: INJECTABLE
Applicant: COR THERAPEUTICS INC
Active Ingredient(s): EPTIFIBATIDE
OTC/RX Status: RX

Application #: 019058 Labeling Supplement#: 013 To Original New Drug Application
Approval Date: 21-JUL-99
Trade Name: TENORMIN
Dosage Form: INJECTABLE
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): ATENOLOL
OTC/RX Status: RX

Application #: 018760 Labeling Supplement#: 023 To Original New Drug Application
Approval Date: 21-JUL-99
Trade Name: TENORETIC
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): ATENOLOL; CHLORTHALIDONE
OTC/RX Status: RX

Application #: 018240 Labeling Supplement#: 026 To Original New Drug Application
Approval Date: 21-JUL-99
Trade Name: TENORMIN
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): ATENOLOL
OTC/RX Status: RX

Application #: 050733 Labeling Supplement#: 001 To Original New Drug Application
Approval Date: 20-JUL-99
Trade Name: ZITHROMAX
Dosage Form: INJECTABLE
Applicant: PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX

Application #: 050638 Labeling Supplement#: 006 To Original New Drug Application
Approval Date: 20-JUL-99
Trade Name: PENICILLIN G POTASSIUM
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): PENICILLIN G POTASSIUM
OTC/RX Status: RX

Application #: 050218 Labeling Supplement#: 047 To Original New Drug Application
Approval Date: 19-JUL-99
Trade Name: CORTISPORIN
Dosage Form: CREAM
Applicant: MONARCH PHARMACEUTICALS INC
Active Ingredient(s): POLYMYXIN B SULFATE; NEOMYCIN SULFATE; HYDROCORTISONE ACETATE
OTC/RX Status: RX

Application #: 050168 Labeling Supplement#: 073 To Original New Drug Application
Approval Date: 19-JUL-99
Trade Name: CORTISPORIN
Dosage Form: OINTMENT
Applicant: MONARCH PHARMACEUTICALS INC
Active Ingredient(s): POLYMYXIN B SULFATE; BACITRACIN ZINC; NEOMYCIN SULFATE; HYDROCORTISONE
OTC/RX Status: RX

Application #: 020928 Labeling Supplement#: 001 To Original New Drug Application
Approval Date: 19-JUL-99
Trade Name: GLUCAGON
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): GLUCAGON, BIOSYNTHETIC
OTC/RX Status: RX

Application #:020549Labeling Supplement#:006 To Original New Drug Application
Approval Date: 19-JUL-99
Trade Name: FLOVENT
Dosage Form: POWDER
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE DIPROPIONATE
OTC/RX Status: RX

Application #: 050749 Labeling Supplement#: 002 To Original New Drug Application
Approval Date: 14-JUL-99
Trade Name: OMNICEF
Dosage Form: SUSPENSION
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): CEFDINIR
OTC/RX Status: RX

Application #: 050749 Labeling Supplement#: 004 To Original New Drug Application
Approval Date: 13-JUL-99
Trade Name: OMNICEF
Dosage Form: SOLUTION
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): CEFDINIR
OTC/RX Status: RX

Application #: 017398 Labeling Supplement#: 013 To Original New Drug Application
Approval Date: 12-JUL-99
Trade Name: REGONOL
Dosage Form: INJECTABLE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): PYRIDOSTIGMINE BROMIDE
OTC/RX Status: RX

Application #: 020913 Labeling Supplement#: 001 To Original New Drug Application
Approval Date: 09-JUL-99
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020912 Labeling Supplement#: 001 To Original New Drug Application
Approval Date: 09-JUL-99
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018257 Labeling Supplement#: 026 To Original New Drug Application
Approval Date: 07-JUL-99
Trade Name: TONOCARD
Dosage Form: TABLET
Applicant: ASTRA PHARMACEUTICALS LP
Active Ingredient(s): TOCAINIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020343 Labeling Supplement#: 008 To Original New Drug Application
Approval Date: 06-JUL-99
Trade Name: PRIMACOR IN 5% DEXTROSE
Dosage Form: INJECTABLE
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX

Application #: 019436 Labeling Supplement#: 012 To Original New Drug Application
Approval Date: 06-JUL-99
Trade Name: PRIMACOR
Dosage Form: INJECTABLE
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX

Application #: 020413 Labeling Supplement#: 003 To Original New Drug Application
Approval Date: 01-JUL-99
Trade Name: ZERIT
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB COMPANY
Active Ingredient(s): STAVUDINE
OTC/RX Status: RX

Application #: 020412 Labeling Supplement#: 010 To Original New Drug Application
Approval Date: 01-JUL-99
Trade Name: ZERIT
Dosage Form: SOLUTION
Applicant: BRISTOL MYERS SQUIBB COMPANY
Active Ingredient(s): STAVUDINE
OTC/RX Status: RX

Application #: 020156 Labeling Supplement#: 021 To Original New Drug Application
Approval Date: 01-JUL-99
Trade Name: VIDEX
Dosage Form: POWDER OF RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB COMPANY
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX

Application #: 020155 Labeling Supplement#: 020 To Original New Drug Application
Approval Date: 01-JUL-99
Trade Name: VIDEX
Dosage Form: POWDER OF RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB COMPANY
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX

Application #: 020154 Labeling Supplement#: 028 To Original New Drug Application
Approval Date: 01-JUL-99
Trade Name: VIDEX
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB COMPANY
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX