03/12/99 01-MAR-99 - 12-MAR-99
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 075207
Tentative Approval Date: 26-FEB-99
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 075301
Tentative Approval Date: 26-FEB-99
Trade Name: DOXAZOSIN MESYLATE
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS, INC
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX
Original Abbreviated Application #: 075091
Tentative Approval Date: 26-FEB-99
Trade Name: CARBIDOPA AND LEVODOPA EXTENDED RELEASE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: MYLAN LABORATORIES INC
Active Ingredient(s): CARBIDOPA, LEVODOPA
OTC/RX Status: RX
Original Abbreviated Application #: 04704
Tentative Approval Date: 25-FEB-99
Trade Name: PROPOFOL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): PROPOFOL
OTC/RX Status: RX
Original Abbreviated Application #: 075355
Tentative Approval Date: 23-FEB-99
Trade Name: LABETALOL HCL
Dosage Form: INJECTABLE
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 075212
Tentative Approval Date: 23-FEB-99
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: OTC
Original Abbreviated Application # 075063
Approval Date: 09-FEB-99
Trade Name: ALBUTEROL SULFATE
Dosage Form: SOLUTION
Applicant: HI TECH PHARMACAL CO INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Original Abbreviated Application # 075391
Approval Date: 08-FEB-99
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: SOLUTION
Applicant: ALTANA INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Labeling Supplements to Original New Drug Applications
Application #: 006095 Labeling Supplement #: 038
To Original New Drug Application
Approval Date: 26-FEB-99
Trade Name: TUBOCURARINE CHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): TUBOCURARINE CHLORIDE
OTC/RX Status: RX
Application #: 006095 Labeling Supplement #: 034
To Original New Drug Application
Approval Date: 26-FEB-99
Trade Name: TUBOCURARINE CHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): TUBOCURARINE CHLORIDE
OTC/RX Status: RX
Application #: 020714 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 25-FEB-99
Trade Name: NICOTROL INHALER
Dosage Form: INHALANT
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): NICOTINE
OTC/RX Status: RX
Application #: 020711 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 24-FEB-99
Trade Name:ZYBAN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020711 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 24-FEB-99
Trade Name: ZYBAN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX
Application #: 050155 Labeling Supplement#: 037
To Original New Drug Application
Approval Date: 23-FEB-99
Trade Name: CHLOROMYCETIN SODIUM SUCCINATE
Dosage Form: INJECTABLE
Applicant: PARKEDALE PHARMACEUTICALS, INC
Active Ingredient(s): STERILE CHLORAMPHENICOL SODIUM SUCCINATE
OTC/RX Status: RX
Application #: 020607 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 22-FEB-99
Trade Name: ARTHROTEC
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): DICLOFENAC SODIUM; MISOPROSTOL
OTC/RX Status: RX
Application #: 020406 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 22-FEB-99
Trade Name: PREVACID
Dosage Form: CAPSULE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Application #: 020090 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 22-FEB-99
Trade Name: DIFLUCAN
Dosage Form: SUSPENSION
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX
Application #: 019950 Labeling Supplement #: 028
To Original New Drug Application
Approval Date: 22-FEB-99
Trade Name: DIFLUCAN
Dosage Form: INJECTABLE
Applicant: PFIZER INC
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX
Application #: 019949 Labeling Supplement #: 027
To Original New Drug Application
Approval Date: 22-FEB-99
Trade Name: DIFLUCAN
Dosage Form: TABLET
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX
Application #: 018248 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 22-FEB-99
Trade Name: OXYTOCIN
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): OXYTOCIN
OTC/RX Status: RX
Application #: 020507 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 17-FEB-99
Trade Name: TECZEM
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ENALAPRIL MALEATE; DILTIAZEM MALATE
OTC/RX Status: RX
Application #: 020403 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 17-FEB-99
Trade Name: ZOFRAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020225 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 17-FEB-99
Trade Name: IMDUR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: SCHERING CORP
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX
Application #: 020201 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 17-FEB-99
Trade Name: DOBUTAMINE HCL IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DOBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020145 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 17-FEB-99
Trade Name: NITRO-DUR
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX
Application #: 020007 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 17-FEB-99
Trade Name: ZOFRAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019778 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 17-FEB-99
Trade Name: PRINZIDE
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LISINOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Application #: 019558 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 17-FEB-99
Trade Name: PRINIVIL
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX
Application #: 019309 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 17-FEB-99
Trade Name: VASOTEC IV
Dosage Form: INJECTION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX
Application #: 019221 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 17-FEB-99
Trade Name: VASERETIC
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Application #: 018998 Labeling Supplement#: 057
To Original New Drug Application
Approval Date: 17-FEB-99
Trade Name: VASOTEC
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX
Application #: 050686 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 16-FEB-99
Trade Name: CEDAX
Dosage Form: SUSPENSION
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): CEFTIBUTEN DIHYDRATE
OTC/RX Status: RX
Application #: 050685 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 16-FEB-99
Trade Name: CEDAX
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): CEFTIBUTEN DIHYDRATE
OTC/RX Status: RX
Application #: 050632 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 16-FEB-99
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX
Application #: 050580 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 16-FEB-99
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX
Application #: 50580 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 16-FEB-99
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX
Application #: 020114 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 16-FEB-99
Trade Name: ASTELIN
Dosage Form: SPRAY
Applicant: WALLACE LABORATORIES DIV CARTER WALLACE INC
Active Ingredient(s): AZELASTINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020830 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 12-FEB-99
Trade Name: SINGULAIR
Dosage Form: TABLET, CHEWABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX
Application #: 020829 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 12-FEB-99
Trade Name: SINGULAIR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX
Application #: 009175 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 11-FEB-99
Trade Name: FURADANTIN
Dosage Form: SUSPENSION
Applicant: DURA PHARMACEUTICALS INC
Active Ingredient(s): NITROFURANTOIN
OTC/RX Status: RX
Application #: 020708 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 11-FEB-99
Trade Name: LUPRON DEPOT-3
Dosage Form: SUSPENSION
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX
Application #: 050679 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 08-FEB-99
Trade Name: MAXIPIME
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFEPIME HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018117 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 08-FEB-99
Trade Name: AZMACORT
Dosage Form: AEROSOL, METERED
Applicant: RHONE POULENC RORER CENTRAL RESEARCH
Active Ingredient(s): TRIAMCINOLONE ACETONIDE
OTC/RX Status: RX
Application #: 017573 Labeling Supplement#: 040
To Original New Drug Application
Approval Date: 08-FEB-99
Trade Name: VANCERIL
Dosage Form: AEROSOL, METERED
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): BECLOMETHASONE DIPROPIONATE
OTC/RX Status: RX
Application #: 050630 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 04-FEB-99
Trade Name: PRIMAXIN I.M.
Dosage Form: INJECTABLE
Applicant: MERCK AND CO INC
Active Ingredient(s): IMIPENEM; CILASTATIN SODIUM
OTC/RX Status: RX
Application #: 020144 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 03-FEB-99
Trade Name: TRANSDERM-NITRO
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX
Application #: 019810 Labeling Supplement#: 057
To Original New Drug Application
Approval Date: 03-FEB-99
Trade Name: PRILOSEC
Dosage Form: CAPSULE, DELAYED RELEASE PELLETS
Applicant: ASTRA MERCK INC
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX
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Date created: March 15, 1999; last update: June 20, 2005
