Drug Approvals for November 1999
Definitions and Notes
Original New Drug Applications
Original Application #: 021035
Approval Date: 30-NOV-99
Trade Name: KEPPRA
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: UCB PHARMA INC
Active Ingredient(s): LEVETRIACETAM
OTC/RX Status: RX
Indication(s): Provides for the use of Keppra as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy
Original Application #: 021076
Approval Date: 29-NOV-99
Trade Name: ALEVE COLD AND SINUS
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: BAYER CORP CONSUMER CARE DIV
Active Ingredient(s): NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
OTC/RX Status: OTC
Indication(s): For the temporary relief of cold, sinus and flu symptoms
Original Application #: 020884
Approval Date: 22-NOV-99
Trade Name: AGGRENOX
Chemical Type: 4
Therapeutic Potential: P
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): ASPIRIN; DIPYRIDAMOLE
OTC/RX Status: RX
Indication(s): For the use of Aggrenox to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis
Original Application #: 020744
Approval Date: 18-NOV-99
Trade Name: CUROSURF
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: SUSPENSION
Applicant: DEY LABORATORIES INC
Active Ingredient(s): PORACTANT ALPHA
OTC/RX Status: RX
Indication(s): For the treatment (rescue) of Respiratory Distress Syndrome (RDS) in premature infants
Efficacy Supplemental New Drug Applications
Application #: 020779 Efficacy Supplement#: 022
Type: SE2 to Original New Drug Application
Approval Date: 24-NOV-99
Trade Name: VIRACEPT
Dosage Form: TABLET
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX
Efficacy Claim: For a 1250mg twice daily dosing regimen of Viracept in combination with other antiretroviral therapies as an alternate dosing regimen for the standard dosing regimen of 750mg three times daily in combination with other antiretrovirals for the treatment of HIV infection
Application #: 020778 Efficacy Supplement#: 011
Type: SE2 to Original New Drug Application
Approval Date: 24-NOV-99
Trade Name: VIRACEPT
Dosage Form: POWDER, FOR ORAL SOLUTION
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX
Efficacy Claim:For a 1250mg twice daily dosing regimen of Viracept in combination with other antiretroviral therapies as an alternate dosing regimen for the standard dosing regimen of 750mg three times daily in combination with other antiretrovirals for the treatment of HIV infection
Application #: 019766 Efficacy Supplement#: 036
Type: SE1 to Original New Drug Application
Approval Date: 22-NOV-99
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of Type III hyperlipoproteinemia
Application #: 019766 Efficacy Supplement#: 034
Type: SE1 to Original New Drug Application
Approval Date: 22-NOV-99
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of patients with isolated hypertriglyceridemia (Fredrickson Type IV)
Application #: 020865 Efficacy Supplement#: 001
Type: SE8 to Original New Drug Application
Approval Date: 16-NOV-99
Trade Name: MAXALT
Dosage Form: TABLET
Applicant: MERCK & CO, INC
Active Ingredient(s): RIZATRIPTAN
OTC/RX Status: RX
Efficacy Claim: For acute treatment of migraine
Application #: 020864 Efficacy Supplement#: 003
Type: SE8 to Original New Drug Application
Approval Date: 16-NOV-99
Trade Name: MAXALT
Dosage Form: TABLET
Applicant: MERCK & CO, INC
Active Ingredient(s): RIZATRIPTAN
OTC/RX Status: RX
Efficacy Claim: For acute treatment of migraine
Application #: 020076 Efficacy Supplement#: 011
Type: SE6 to Original New Drug Application
Approval Date: 12-NOV-99
Trade Name: HABITROL
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: NOVARTIS CONSUMER HEALTH INC
Active Ingredient(s): NICOTINE
OTC/RX Status: RX
Efficacy Claim:Provides for the over-the-counter (OTC) marketing of Habitrol (nicotine transdermal system),21, 14, and 7 mg/day patches to adults (those who are at least 18 years of age) for use as an aid to stop smoking cigarettes.
Application #: 050739 Efficacy Supplement #: 002
Type: SE2 to Original New Drug Application
Approval Date: 08-NOV-99
Trade Name: OMNICEF
Dosage Form: CAPSULE
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): CEFDINIR
OTC/RX Status: RX
Efficacy Claim: Provides for the use of Omnicef Capsules for a 5-day dosing regiment (300 mg BID) for the treatment of acute exacerbations of chronic bronchitis.
Approvable Original New Drug Applications
Original Application #: 020125
Approvable Date: 30-NOV-99
Trade Name: ACCURETIC
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Original Abbreviated Application #: 075366
Tentative Approval Date: 02-NOV-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 # 075524
Approval Date: 29-NOV-99
Trade Name: LABETALOL HCL
Dosage Form: INJECTABLE
Applicant: TAYLOR PHARMACEUTICALS
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075431
Approval Date: 29-NOV-99
Trade Name: LABETALOL HCL
Dosage Form: INJECTABLE
Applicant: TAYLOR PHARMACEUTICALS
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075355
Approval Date: 29-NOV-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 # 075310
Approval Date: 29-NOV-99
Trade Name: BUPROPION HCL
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075240
Approval Date: 29-NOV-99
Trade Name: LABETALOL HCL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075239
Approval Date: 29-NOV-99
Trade Name: LABETALOL HCL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040312
Approval Date: 19-NOV-99
Trade Name: INNOFEM
Dosage Form: TABLET
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Original Abbreviated Application # 075076
Approval Date: 12-NOV-99
Trade Name: NITROGLYCERIN
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: MYLAN TECHNOLOGIES, INC
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX
Original Abbreviated Application # 075075
Approval Date: 12-NOV-99
Trade Name: NITROGLYCERIN
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: MYLAN TECHNOLOGIES, INC
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX
Original Abbreviated Application # 075073
Approval Date: 12-NOV-99
Trade Name: NITROGLYCERIN
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: MYLAN TECHNOLOGIES, INC
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX
Original Abbreviated Application # 074992
Approval Date: 12-NOV-99
Trade Name: NITROGLYCERIN
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX
Original Abbreviated Application # 075343
Approval Date: 09-NOV-99
Trade Name: ALBUTEROL SULFATE
Dosage Form: SOLUTION
Applicant: STERIPAK LTD
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Original Abbreviated Application # 075342
Approval Date: 04-NOV-99
Trade Name: BUTORPHANOL TARTRATE
Dosage Form: INJECTABLE
Applicant: MERIDIAN MEDICAL TECHNOLOGIES INC
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX
Original Abbreviated Application # 075299
Approval Date: 03-NOV-99
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: INJECTABLE
Applicant: BAXTER PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX
Original Abbreviated Application # 075316
Approval Date: 02-NOV-99
Trade Name: TICLOPIDINE HCL
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040296
Approval Date: 01-NOV-99
Trade Name: ESTROPIPATE
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): ESTROPIPATE
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 075040
Tentative Approval Date: 24-NOV-99
Trade Name: PROPOFOL
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE
Active Ingredient(s): PROPOFOL OTC/RX Status: RX
Original Abbreviated Application #: 075421
Tentative Approval Date: 23-NOV-99
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: BEN VENUE LABORATORIES INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE OTC/RX Status: RX
Original Abbreviated Application #: 075429
Tentative Approval Date: 16-NOV-99
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 075263
Tentative Approval Date: 08-NOV-99
Trade Name: MIDAZOLAM HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: ASTRA PHARMACEUTICALS LP
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 017060 Labeling Supplement#: 064
To Original New Drug Application
Approval Date: 30-NOV-99
Trade Name: NOR-QD
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): NORETHINDRONE
OTC/RX Status: RX
Application #: 020665 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 29-NOV-99
Trade Name: DIOVAN
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): VALSARTAN
OTC/RX Status: RX
Application #: 020560 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 24-NOV-99
Trade Name: FOSAMAX
Dosage Form: TABLETS
Applicant: MERCK RESEARCH LABORATORIES
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX
Application #: 020522 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 24-NOV-99
Trade Name: NUTROPIN AQ
Dosage Form: INJECTABLE
Applicant: GENENTECH INC
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Application #: 019676 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 24-NOV-99
Trade Name: NUTROPIN
Dosage Form: INJECTABLE
Applicant: GENENTECH INC
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Application #: 019415 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 24-NOV-99
Trade Name: FERTINEX
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): UROFOLLITROPIN
OTC/RX Status: RX
Application #: 050108 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 26-NOV-99
Trade Name: COLY-MYCIN M
Dosage Form: INJECTABLE
Applicant: PARKEDALE PHARMACEUTICALS INC
Active Ingredient(s): COLISTIMETHATE SODIUM
OTC/RX Status: RX
Application #: 017876 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 24-NOV-99
Trade Name: LOESTRIN 21 1/20
Dosage Form: TABLET
Applicant: PARKE DAVIS
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX
Application #: 017875 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 24-NOV-99
Trade Name: LOESTRIN 21 1.5/30
Dosage Form: TABLET
Applicant: PARKE DAVIS
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX
Application #: 017355 Labeling Supplement#: 044
To Original New Drug Application
Approval Date: 24-NOV-99
Trade Name: LOESTRIN FE 1.5/30
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX
Application #: 017354 Labeling Supplement#: 042
To Original New Drug Application
Approval Date: 24-NOV-99
Trade Name: LOESTRIN FE 1/20
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX
Application #: 020328 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 23-NOV-99
Trade Name: HUMEGON
Dosage Form: INJECTABLE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): MENOTROPINS
OTC/RX Status: RX
Application #: 017692 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 23-NOV-99
Trade Name: PREGNYL
Dosage Form: INJECTABLE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): GONADOTROPIN, CHORIONIC
OTC/RX Status: RX
Application #: 017430 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 23-NOV-99
Trade Name: NEGGRAM
Dosage Form: SUSPENSION
Applicant: SANOFI SYNTHELABO INC
Active Ingredient(s): NALIDIXIC ACID
OTC/RX Status: RX
Application #: 017430 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 23-NOV-99
Trade Name: NEGGRAM
Dosage Form: SUSPENSION
Applicant: SANOFI SYNTHELABO INC
Active Ingredient(s): NALIDIXIC ACID
OTC/RX Status: RX
Application #: 014214 Labeling Supplement#: 051
To Original New Drug Application
Approval Date: 23-NOV-99
Trade Name: NEGGRAM
Dosage Form: TABLET
Applicant: SANOFI SYNTHELABO INC
Active Ingredient(s): NALIDIXIC ACID
OTC/RX Status: RX
Application #: 014214 Labeling Supplement#: 050
To Original New Drug Application
Approval Date: 23-NOV-99
Trade Name: NEGGRAM
Dosage Form: TABLET
Applicant: SANOFI SYNTHELABO INC
Active Ingredient(s): NALIDIXIC ACID
OTC/RX Status: RX
Application #: 019697 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 22-NOV-99
Trade Name: ORTHO TRI-CYCLEN
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHA RMACEUTICAL CORP
Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRAD IOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE
OTC/RX Status: RX
Application #: 019653 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 22-NOV-99
Trade Name: ORTHO CYCLEN-21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORGESTIMATE; ETHINYL ESTRADIOL
OTC/RX Status: RX
Application #: 019339 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 19-NOV-99
Trade Name: HEPARIN SODIUM IN DEXTROSE 5% INJECTION IN FLEXIBLE CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX
Application #: 018916 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 19-NOV-99
Trade Name: HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION IN FLEXIBLE CONTAINERS
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX
Application #:020632Labeling Supplement#:006
To Original New Drug Application
Approval Date: 12-NOV-99
Trade Name: MERIDIA
Dosage Form: CAPSULE
Applicant: KNOLL PHARMACEUTICAL CO SUB BASF CORP
Active Ingredient(s): SIBUTRAMINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 016954 Labeling Supplement #: 085
To Original New Drug Application
Approval Date: 10-NOV-99
Trade Name: MICRONOR
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHA RMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE
OTC/RX Status: RX
Application #: 019921 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 09-NOV-99
Trade Name: OCUFLOX
Dosage Form: SOLUTION/DROPS
Applicant: ALLERGAN INC
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX
Application #: 017473 Labeling Supplement #: 036
To Original New Drug Application
Approval Date: 09-NOV-99
Trade Name: ORAP
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): PIMOZIDE
OTC/RX Status: RX
Application #: 017473 Labeling Supplement #: 033
To Original New Drug Application
Approval Date: 09-NOV-99
Trade Name: ORAP
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): PIMOZIDE
OTC/RX Status: RX
Application #: 017962 Labeling Supplement #: 053
To Original New Drug Application
Approval Date: 09-NOV-99
Trade Name: PARLODEL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): BROMOCRIPTINE MESYLATE
OTC/RX Status: RX
Application #: 018705 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 04-NOV-99
Trade Name: NITROLINGUAL
Dosage Form: AEROSOL
Applicant: G POHL BOSKAMP GMGH CO
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX
Application #: 018705 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 04-NOV-99
Trade Name: NITROLINGUAL
Dosage Form: AEROSOL
Applicant: G POHL BOSKAMP GMGH CO
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX
Application #: 020578 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 03-NOV-99
Trade Name: ZOLADEX
Dosage Form: IMPLANT
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): GOSERELIN ACETATE
OTC/RX Status: RX
Application #: 019726 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 03-NOV-99
Trade Name: ZOLADEX
Dosage Form: IMPLANT
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): GOSERELIN ACETATE
OTC/RX Status: RX
Application #: 017078 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 03-NOV-99
Trade Name: DEXEDRINE
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): DEXTROAMPHETAMINE SULFATE
OTC/RX Status: RX
Application #: 020444 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 02-NOV-99
Trade Name: FLOLAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): EPOPROSTENOL SODIUM
OTC/RX Status: RX
Application #: 020084 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 02-NOV-99
Trade Name: IOBENGUANE SULFATE I 131
Dosage Form: INJECTABLE
Applicant: CIS US INC
Active Ingredient(s): IOBENGUANE SULFATE I 131
OTC/RX Status: RX
Application #: 005619 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 02-NOV-99
Trade Name: AMINOHIPPURATE SODIUM
Dosage Form: INJECTABLE
Applicant: MERCK AND CO INC
Active Ingredient(s): AMINOHIPPURATE SODIUM
OTC/RX Status: RX
