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Drug Approvals for November 1998
Definitions and Notes
November 1998
Original New Drug Applications
Original Application #: 021008
Approval Date: 25-NOV-98
Trade Name: SANDOSTATIN LAR
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP
Active Ingredient(s): OCTREOTIDE ACETATE
OTC/RX Status: RX
Indication(s):For the reduction of growth hormone and IGF-1 in acromegaly, the suppression of severe diarrhea and flushing associated with malignant carcinoid syndrome and for the treatment of the profuse watery diarrhea associated with VIPoma (vasoactive intestinal peptide tumor)
Original Application #: 020943
Approval Date: 25-NOV-98
Trade Name: VERELAN PM
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: ELAN PHARMA INC
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX
Indication(s):For the management of essential hypertension
Original Application #: 020901
Approval Date: 24-NOV-98
Trade Name: METROLOTION
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: LOTION
Applicant: GALDERMA LABORATORIES INC
Active Ingredient(s): METRONIDAZOLE
OTC/RX Status: RX
Indication(s): For the treatment of inflammatory papules and pustules of rosacea
Original Application #: 020574
Approval Date: 24-NOV-98
Trade Name: GYNE-LOTRIMIN 3
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: SCHERING PLOUGH HEALTHCARE PRODUCTS INC
Active Ingredient(s): CLOTRIMAZOLE
OTC/RX Status: OTC
Indication(s):For the treatment of vulvovaginal candidiasis
Original Application #: 021068
Approval Date: 20-NOV-98
Trade Name: ROCALTROL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): CALCITRIOL
OTC/RX Status: RX
Indication(s):For the treatment of secondary hyperparathyroidism in patients (including pediatric patients) with moderate to severe chronic renal failure (creatinine clearance of 15 to 55ml/min) who are not yet undergoing dialysis
Original Application #: 020907
Approval Date: 18-NOV-98
Trade Name: ACTIVELLE
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: NOVO NORDISK A/S
Active Ingredient(s): ESTRADIOL; NORETHINDRONE ACETATE
OTC/RX Status: RX
Indication(s): For the treatment of moderate to severe vasomotor symptoms associated with the menopause and in the treatment of vulvar and vaginal atrophy in women with an intact uterus
Original Application #: 020850
Approval Date: 10-NOV-98
Trade Name: MICARDIS
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM
Active Ingredient(s): TELMISARTAN
OTC/RX Status: RX
Indication(s): For the treatment of hypertension
Original Application #: 020747
Approval Date: 04-NOV-98
Trade Name: ACTIQ
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ANESTA CORP
Active Ingredient(s): ORAL TRANSMUCOSAL FENTANYL CITRATE
OTC/RX Status: RX
Indication(s): For the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain
Efficacy Supplemental New Drug Applications
Application #: 020671 Efficacy Supplement#: 004
Type: SE1 to Original New Drug Application
Approval Date: 30-NOV-98
Trade Name: HYCAMTIN
Dosage Form:INJECTABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): TOPOTECAN HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim:In the treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy
Application #: 018044 Efficacy Supplement#: 025
Type: SE1 to Original New Drug Application
Approval Date: 20-NOV-98
Trade Name: ROCALTROL
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): CALCITRIOL
OTC/RX Status: RX
Efficacy Claim:For the treatment of secondary hyperparathyroidism in patients (including pediatric patients) with moderate to severe chronic renal failure (creatinine clearance of 15 to 55ml/min) who are not yet undergoing dialysis
Application #: 020394 Efficacy Supplement #: 001
Type: SE1 to Original New Drug Application
Approval Date: 09-NOV-98
Trade Name: ATROVENT
Dosage Form: SPRAY, METERED
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): IPRATROPIUM BROMIDE
OTC/RX Status: RX
Efficacy Claim:For use in symptomatic relief of rhinorrhea associated with the common cold in children age 5 to 11 years
Application #: 020325 Efficacy Supplement #: 007
Type: SE2 to Original New Drug Application
Approval Date: 09-NOV-98
Trade Name: PEPCID AC
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC
Efficacy Claim:For relief of heartburn associated with acid indigestion and sour stomach and for prevention of heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Approvable Original New Drug Applications
Original Abbreviated Application # 075352
Approval Date: 30-NOV-98
Trade Name: SELEGILINE HCL
Dosage Form: CAPSULE
Applicant: ESI LEDERLE INC
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074739
Approval Date: 30-NOV-98
Trade Name: AMIODARONE HCL
Dosage Form: TABLET
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075152
Approval Date: 27-NOV-98
Trade Name: DICLOFENAC POTASSIUM
Dosage Form: TABLET
Applicant: WATSON LABORATORIES
Active Ingredient(s): DICLOFENAC POTASSIUM
OTC/RX Status: RX
Original Abbreviated Application # 075147
Approval Date: 27-NOV-98
Trade Name: ISOSORBIDE MONONITRATE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX
Original Abbreviated Application # 040300
Approval Date: 27-NOV-98
Trade Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: MALLINCKRODT INC
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040288
Approval Date: 27-NOV-98
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): HYDROCODONE BITARTRATE; ACETAMINOPHEN
OTC/RX Status: RX
Original Abbreviated Application # 075109
Approval Date: 25-NOV-98
Trade Name: GAUNFACINE HCL
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): GUANFACINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074756
Approval Date: 25-NOV-98
Trade Name: SELEGILINE HCL
Dosage Form: TABLET
Applicant: BAKER NORTON PHARMACEUTICALS INC
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040276
Approval Date: 25-NOV-98
Trade Name: PHENTERMINE HCL
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075226
Approval Date: 24-NOV-98
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX
Original Abbreviated Application # 075229
Approval Date: 20-NOV-98
Trade Name: DICLOFENAC POTASSIUM
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): DICLOFENAC POTASSIUM
OTC/RX Status: RX
Original Abbreviated Application # 074726
Approval Date: 20-NOV-98
Trade Name: POTASSIUM SODIUM
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: UPSHER SMITH LABORATORIES INC
Active Ingredient(s): POTASSIUM CHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040140
Approval Date: 20-NOV-98
Trade Name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DIPHENHYDRAMINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075224
Approval Date: 16-NOV-98
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: SOLUTION
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX
Original Abbreviated Application # 075205
Approval Date: 13-NOV-98
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: EMULSION, CREAM
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX
Original Abbreviated Application # 075185
Approval Date: 13-NOV-98
Trade Name: DICLOFENAC SODIUM
Dosage Form: TABLET, DELAYED RELEASE
Applicant: CARLSBAD TECHNOLOGY INC
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 075193
Tentative Approval Date: 30-NOV-98
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application #: 075240
Tentative Approval Date: 27-NOV-98
Trade Name: LABETALOL HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 075239
Tentative Approval Date: 27-NOV-98
Trade Name: LABETALOL HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 075001
Tentative Approval Date: 23-NOV-98
Trade Name: ASTEMIZOLE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): ASTEMIZOLE
OTC/RX Status: RX
Original Abbreviated Application #: 075194
Tentative Approval Date: 20-NOV-98
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application #: 075192
Tentative Approval Date: 20-NOV-98
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application #: 075119
Tentative Approval Date: 16-NOV-98
Trade Name: BUSPIRONE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: EGIS PHARMACEUTICALS
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 075272
Tentative Approval Date: 10-NOV-98
Trade Name: BUSPIRONE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 074686
Tentative Approval Date: 10-NOV-98
Trade Name: GLYBURIDE
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 020665 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 27-NOV-98
Trade Name: DIOVAN
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): VALSARTAN
OTC/RX Status: RX
Application #: 020895 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 24-NOV-98
Trade Name: VIAGRA
Dosage Form: TABLET
Applicant: PFIZER AGRICULTURAL DIV
Active Ingredient(s): SILDENAFIL CITRATE
OTC/RX Status: RX
Application #: 020815 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 24-NOV-98
Trade Name: EVISTA
Dosage Form: TABLET
Applicant: ELI LILLY & COMPANY
Active Ingredient(s): RALOXIFENE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020387 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 24-NOV-98
Trade Name: HYZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES
Active Ingredient(s): LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Application #: 020386 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 24-NOV-98
Trade Name: COZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LOSARTAN POTASSIUM
OTC/RX Status: RX
Application #: 018276 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 24-NOV-98
Trade Name: XANAX
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ALPRAZOLAM
OTC/RX Status: RX
Application #: 019402 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 23-NOV-98
Trade Name: HISMANAL
Dosage Form: TABLET
Applicant: JANSSEN PHARMACEUTICA INC
Active Ingredient(s): ASTEMIZOLE
OTC/RX Status: RX
Application #: 009218 Labeling Supplement#: 087
To Original New Drug Application
Approval Date: 23-NOV-98
Trade Name: COUMADIN
Dosage Form: TABLET
Applicant: DUPONT PHARMACEUTICALS COMPANY
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX
Application #: 050675 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 20-NOV-98
Trade Name: VANTIN
Dosage Form: SOLUTION
Applicant: PHARMACIA & UPJOHN
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX
Application #: 050674 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 20-NOV-98
Trade Name: VANTIN
Dosage Form: TABLET
Applicant: PHARMACIA & UPJOHN
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX
Application #: 050675 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 20-NOV-98
Trade Name: VANTIN
Dosage Form: SOLUTION
Applicant: PHARMACIA & UPJOHN
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX
Application #:017377Labeling Supplement#:056
To Original New Drug Application
Approval Date: 17-NOV-98
Trade Name: BACTRIM
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Application #: 015539 Labeling Supplement #: 051
To Original New Drug Application
Permitted Date: 17-NOV-98
Trade Name: SERAX
Dosage Form: CAPSULE AND TABLET
Applicant: WYETH AYERST RESEARCH
Active Ingredient(s): OXAZEPAM
OTC/RX Status: RX
Application #: 020697 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 16-NOV-98
Trade Name: TASMAR
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): TOLCAPONE
OTC/RX Status: RX
Application #: 050619 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 13-NOV-98
Trade Name: MYCOSTATIN
Dosage Form: PASTILLE
Applicant: ER SQUIBB AND SONS INC
Active Ingredient(s): NYSTATIN LOZENGES
OTC/RX Status: RX
Application #: 018706 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 12-NOV-98
Trade Name: HYDERGINE LC
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ERGOLOID MESYLATES
OTC/RX Status: RX
Application #: 018418 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 12-NOV-98
Trade Name: HYDERGINE
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ERGOLOID MESYLATES
OTC/RX Status: RX
Application #: 017993 Labeling Supplement #: 027
To Original New Drug Application
Approval Date: 12-NOV-98
Trade Name: HYDERGINE
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ERGOLOID MESYLATES
OTC/RX Status: RX
Application #: 009087 Labeling Supplement #: 045
To Original New Drug Application
Approval Date: 12-NOV-98
Trade Name: HYDERGINE
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ERGOLOID MESYLATES
OTC/RX Status: RX
Application #: 050549 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 10-NOV-98
Trade Name: MEZLIN
Dosage Form:INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): STERILE MEZLOCILLIN SODIUM
OTC/RX Status: RX
Application #: 020387 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 10-NOV-98
Trade Name: HYZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES
Active Ingredient(s): LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Application #: 018655 Labeling Supplement #: 032
To Original New Drug Application
Approval Date: 10-NOV-98
Trade Name: NORPACE CR
Dosage Form: CAPSULE
Applicant: GD SEARLE AND CO
Active Ingredient(s): DISOPYRAMIDE PHOSPHATE
OTC/RX Status: RX
Application #: 017447 Labeling Supplement #: 054
To Original New Drug Application
Approval Date: 10-NOV-98
Trade Name: NORPACE
Dosage Form: CAPSULE
Applicant: GD SEARLE AND CO
Active Ingredient(s): DISOPYRAMIDE PHOSPHATE
OTC/RX Status: RX
Application #: 013400 Labeling Supplement #: 085
To Original New Drug Application
Approval Date: 10-NOV-98
Trade Name: ALDOMET
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): METHYLDOPA
OTC/RX Status: RX
Application #: 017559 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 09-NOV-98
Trade Name: PROVENTIL
Dosage Form: AEROSOL, METERED
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): ALBUTEROL
OTC/RX Status: RX
Application #: 019383 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 06-NOV-98
Trade Name: PROVENTIL
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Application #: 017853 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 06-NOV-98
Trade Name: PROVENTIL
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Application #: 019243 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 06-NOV-98
Trade Name: PROVENTIL
Dosage Form: SOLUTION
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Application #: 018062 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 06-NOV-98
Trade Name: PROVENTIL
Dosage Form: SYRUP
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Application #: 011835 Labeling Supplement #: 060
To Original New Drug Application
Approval Date: 05-NOV-98
Trade Name: HYDRODIURIL
Dosage Form: TABLET
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Application #: 018074 Labeling Supplement #: 028
To Original New Drug Application
Approval Date: 03-NOV-98
Trade Name: PHENDIMETRAZINE TARTRATE
Dosage Form: CAPSULE
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): PHENDIMETRAZINE TARTRATE
OTC/RX Status: RX
Application #: 000793 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 04-NOV-98
Trade Name: BUTISOL SODIUM
Dosage Form: TABLET
Applicant: WALLACE LABORATORIES DIV CARTER WALLACE INC
Active Ingredient(s): BUTABARBITAL SODIUM
OTC/RX Status: RX
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Date created: Dec 22., 1998; last updated; June 22, 2005 |
