Drug Approvals for February 2000

Definitions and Notes

Original New Drug Applications

Original Application #: 021015
Approval Date: 28-FEB-00
Trade Name: ANDROGEL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GEL
Applicant: UNIMED PHARMACEUTICALS INC
Active Ingredient(s): TESTOSTERONE
OTC/RX Status: RX
Indication(s): For replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

Original Application #: 020872
Approval Date: 25-FEB-00
Trade Name: ALLEGRA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant:AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): FEXOFENADINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the relief of symptoms associated with seasonal allergic rhinitis and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older

Original Application #: 021114
Approval Date: 23-FEB-00
Trade Name: BETAXON
Chemical Type: 2
Therapeutic Potential: P
Dosage Form: SUSPENSION, DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): LEVOBETAXOLOL HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For lowering intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension

Original Application #: 021151
Approval Date: 22-FEB-00
Trade Name: BETAPACE AF
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the prolongation of time to recurrence of symptomatic AFIB/AFL in patients with symptomatic AFIB/AFL, with or without structural heart disease but in the absence of uncompensated congestive heart failure

Original Application #: 021084
Approval Date: 17-FEB-00
Trade Name: SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS (SERPACWA)
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CREAM, AUGMENTED
Applicant: UNITED STATES ARMY OFFICE SURGEON GENERAL
Active Ingredient(s): POLYTETRAFLUOROETHYLENE; PERFLUOROALKYLPOLYETHER
OTC/RX Status: RX
Indication(s): Provides for the use of Skin Exposure Reduction Paste Against Chemical Warfare Agents (SERPACWA) only in conjunction with Mission Oriented Protective Posture (MOPP) gear to reduce or delay the absorption of chemical warfare agents through the skin when SERPACWA is applied prior to exposure

Original Application #: 021107
Approval Date: 09-FEB-00
Trade Name: LOTRONEX
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALOSETRON HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of irritable bowel syndrome (IBS) in women whose predominant bowel symptom is diarrhea

Original Application #: 020120
Approval Date: 04-FEB-00
Trade Name: TRINASAL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SPRAY
Applicant: MURO PHARMACEUTICAL INC
Active Ingredient(s): TRIAMCINOLONE ACETONIDE
OTC/RX Status: RX
Indication(s): For the treatment of nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 12 years of age or older

Original Application #: 020987
Approval Date: 02-FEB-00
Trade Name: PROTONIX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): PANTOPRAZOLE SODIUM
OTC/RX Status: RX
Indication(s): For short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis

Efficacy Supplemental New Drug Applications

Application #: 020323 Efficacy Supplement#: 021
Type: SE8 to Original New Drug Application
Approval Date: 25-FEB-00
Trade Name: VIVELLE
Dosage Form: FILM, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORPORATION
Active Ingredient(s): ESTRADIOL TRANSDERMAL SYSTEM
OTC/RX Status: RX
Efficacy Claim: For the treatment of moderate-to-severe vasomotor symptoms associated with the menopause, treatment of vulvar and vaginal atrophy and treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure

Application #: 019012 Efficacy Supplement#: 016
Type: SE1 to Original New Drug Application
Approval Date: 25-FEB-00
Trade Name: MOTRIN MIGRAINE PAIN
Dosage Form: TABLET
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Efficacy Claim: For the treatment of pain of migraine headache

Application #: 050688 Efficacy Supplement#: 012
Type: SE2 to Original New Drug Application
Approval Date: 10-FEB-00
Trade Name: BANAN
Dosage Form: GRANULE, FOR RECONSTITUTION
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX
Efficacy Claim: For the treatment of patients with mild to moderate infections caused by susceptible strains

Application #: 050687 Efficacy Supplement#: 011
Type: SE2 to Original New Drug Application
Approval Date: 10-FEB-00
Trade Name: BANAN
Dosage Form: TABLET
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX
Efficacy Claim: For the treatment of patients with mild to moderate infections caused by susceptible strains

Application #: 019898 Efficacy Supplement#: 032
Type: SE1 to Original New Drug Application
Approval Date: 10-FEB-00
Trade Name: PRAVACHOL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): PRAVASTATIN SODIUM
OTC/RX Status: RX
Efficacy Claim: For the use of pravastatin in patients with evident coronary heart disease to reduce the risk of total mortality by reducing coronary death

Application #: 020972 Efficacy Supplement#: 001
Type: SE7 to Original New Drug Application
Approval Date: 09-FEB-00
Trade Name: SUSTIVA
Dosage Form: CAPSULE
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): EFAVIRENZ
OTC/RX Status: RX
Efficacy Claim: For the treatment of HIV-1 infection

Application #: 019777 Efficacy Supplement#: 037
Type: SE1 to Original New Drug Application
Approval Date: 07-FEB-00
Trade Name: ZESTRIL
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX
Efficacy Claim: For the use of high doses of lisinopril to reduce the risk of the combined outcomes of mortality and hospitalization in patients with congestive heart failure

Application #: 020819 Efficacy Supplement#: 003
Type: SE8 to Original New Drug Application
Approval Date: 02-FEB-2000
Trade Name: ZEMPLAR
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): PARICALCITOL
OTC/RX Status: RX
Efficacy Claim: For the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure

Application #:020635Efficacy Supplement#:007
Type: SE1 to Original New Drug Application
Approval Date: 02-FEB-00
Trade Name: LEVAQUIN
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): LEVOFLOXACIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of levofloxacin susceptible-strains of penicillin-resistant Streptococcus pneumoniae in patients with community-acquired pneumonia

Application #:020634Efficacy Supplement#:008
Type: SE1 to Original New Drug Application
Approval Date: 02-FEB-00
Trade Name: LEVAQUIN
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): LEVOFLOXACIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of levofloxacin susceptible-strains of penicillin-resistant Streptococcus pneumoniae in patients with community-acquired pneumonia

Approvable Original New Drug Applications

Original Application #: 020960
Approvable Date: 23-FEB-00
Trade Name: VESTRA
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): REBOXETINE MESYLATE
OTC/RX Status: RX

Original Application #: 020883
Approvable Date: 18-FEB-00
Trade Name: NOVASTAN
Dosage Form:INJECTABLE
Applicant: TEXAS BIOTECHNOLOGY CORP
Active Ingredient(s): ARGATROBAN
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075440
Approval Date: 28-FEB-00
Trade Name: HALOPERIDOL DECANOATE
Dosage Form: INJECTABLE
Applicant: APOTEX CORP
Active Ingredient(s): HALOPERIDOL DECANOATE
OTC/RX Status: RX

Original Abbreviated Application # 040334
Approval Date: 25-FEB-00
Trade Name: FLUOROURACIL
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): FLUOROURACIL
OTC/RX Status: RX

Original Abbreviated Application # 075182
Approval Date: 24-FEB-00
Trade Name: ESTRADIOL
Dosage Form: FILM, CONTROLLED RELEASE
Applicant:MYLAN TECHNOLOGIES, INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 040373
Approval Date: 23-FEB-00
Trade Name: HYDRALAZINE HCL
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): HYDRALAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075529
Approval Date: 22-FEB-00
Trade Name: TRETINOIN
Dosage Form: GEL
Applicant: SPEAR PHARMACEUTICALS INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Original Abbreviated Application # 074574
Approval Date: 18-FEB-00
Trade Name: DESMOPRESSIN ACETATE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES
Active Ingredient(s): DESMOPRESSIN ACETATE
OTC/RX Status: RX

Original Abbreviated Application # 075555
Approval Date: 18-FEB-00
Trade Name: PEMOLINE
Dosage Form: TABLET, CHEWABLE
Applicant: COPLEY PHARMACEUTICAL, INC
Active Ingredient(s): PEMOLINE
OTC/RX Status: RX

Original Abbreviated Application # 075004
Approval Date: 16-FEB-00
Trade Name: DILTIAZEM HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040337
Approval Date: 16-FEB-00
Trade Name: TRIHEXYPHENIDYL HCL
Dosage Form: TABLET
Applicant: WEST WARD PHARMACEUTICAL CORP
Active Ingredient(s): TRIHEXYPHENIDYL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040327
Approval Date: 15-FEB-00
Trade Name: ORPHENADRINE CITRATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): ORPHENADRINE CITRATE
OTC/RX Status: RX

Original Abbreviated Application # 075368
Approval Date: 15-FEB-00
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: GEL
Applicant: ALTANA INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX

Original Abbreviated Application # 075492
Approval Date: 11-FEB-00
Trade Name: DICLOFENAC SODIUM
Dosage Form: TABLET, SUSTAINED ACTION, FILM COATED
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075140
Approval Date: 11-FEB-00
Trade Name: TERAZOSIN HCL
Dosage Form: CAPSULE
Applicant: MYLAN LABORATORIES INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075176
Approval Date: 09-FEB-00
Trade Name: HALOPERIDOL DECANOATE
Dosage Form: INJECTABLE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): HALOPERIDOL DECANOATE
OTC/RX Status: RX

Original Abbreviated Application # 075584
Approval Date: 07-FEB-00
Trade Name: BUPROPION HCL
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075313
Approval Date: 07-FEB-00
Trade Name: IPRSATROPIUM BROMIDE
Dosage Form: SOLUTION
Applicant: STERIPAK LTD
Active Ingredient(s): IPRATROPIUM BROMIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075482
Tentative Approval Date: 22-FEB-00
Trade Name: ENALAPRIL MALEATE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Application #: 075511
Tentative Approval Date: 18-FEB-00
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075480
Tentative Approval Date: 18-FEB-00
Trade Name: ENALAPRIL MALEATE
Dosage Form: TABLET
Applicant: MYLAN LABORATORIES INC
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Application #: 075388
Tentative Approval Date: 15-FEB-00
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: PHARMAX PRODUCTS INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 017635 Labeling Supplement#: 045
To Original New Drug Application
Approval Date: 28-FEB-00
Trade Name: RINGER'S IRRIGATION IN SEMI-RIGID CONTAINERS
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE
OTC/RX Status: RX

Application #: 020346 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 25-FEB-00
Trade Name: ZYRTEC
Dosage Form: SYRUP
Applicant: PFIZER INC
Active Ingredient(s): CETIRIZINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020236 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 25-FEB-00
Trade Name: SEREVENT
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX

Application #: 019835 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 25-FEB-00
Trade Name: ZYRTEC
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): CETIRIZINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019608 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 25-FEB-00
Trade Name: SILDAFLO
Dosage Form: DRESSING
Applicant: CYPROS PHARMACEUTICAL CORP
Active Ingredient(s): SILVER SULFADIAZINE
OTC/RX Status: RX

Application #: 012649 Labeling Supplement#: 047
To Original New Drug Application
Approval Date: 25-FEB-00
Trade Name: PERIACTIN
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): CYPROHEPTADINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020256 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 24-FEB-00
Trade Name: NEUROLITE
Dosage Form: INJECTABLE
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): TECHNETIUM TC-99M BICISATE KIT
OTC/RX Status: RX

Application #: 020905 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 23-FEB-00
Trade Name: ARAVA
Dosage Form: TABLET
Applicant: AVENTIS PHARMACEUTICALS
Active Ingredient(s): LEFLUNOMIDE
OTC/RX Status: RX

Application #: 020905 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 23-FEB-00
Trade Name: ARAVA
Dosage Form: TABLET
Applicant:AVENTIS PHARMACEUTICALS
Active Ingredient(s): LEFLUNOMIDE
OTC/RX Status: RX

Application #: 019810 Labeling Supplement#: 062
To Original New Drug Application
Approval Date: 23-FEB-00
Trade Name: PRILOSEC
Dosage Form: CAPSULE, DELAYED RELEASE
Applicant: ASTRAZENECA LP
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX

Application #: 018947 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 23-FEB-00
Trade Name: SODIUM LACTATE IN PLASTIC VIALS
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): SODIUM LACTATE
OTC/RX Status: RX

Application #: 018406 Labeling Supplement#: 051
To Original New Drug Application
Approval Date: 23-FEB-00
Trade Name: PHYSIOSOL IN FLEXIBLE CONTAINER
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): SODIUM CHLORIDE; SODIUM ACETATE; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE
OTC/RX Status: RX

Application #: 017637 Labeling Supplement #: 046
To Original New Drug Application
Approval Date: 23-FEB-00
Trade Name: PHYSIOSOL IN SEMI-RIGID CONTAINER
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): SODIUM ACETATE; SODIUM CHLORIDE; MAGNESIUM CHLO RIDE; POTASSIUM CHLORIDE; SODIUM GLUCONATE
OTC/RX Status: RX

Application #: 010515 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 23-FEB-00
Trade Name: ISUPREL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ISOPROTERENOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020839 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 22-FEB-00
Trade Name: PLAVIX
Dosage Form: TABLET
Applicant: SANOFI SYNTHELABO INC
Active Ingredient(s): CLOPIDOGREL BISULFATE
OTC/RX Status: RX

Application #: 009218 Labeling Supplement#: 097
To Original New Drug Application
Approval Date: 17-FEB-00
Trade Name: COUMADIN
Dosage Form: TABLET
Applicant: DUPONT MERCK PHARMACEUTICAL CO
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX

Application #: 020165 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 16-FEB-00
Trade Name: NICODERM
Dosage Form: FILM, CONTROLLED RELEASE
Applicant:AVENTIS PHARMACEUTICALS
Active Ingredient(s): NICOTINE
OTC/RX Status: RX

Application #: 020408 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 15-FEB-00
Trade Name: TRUSOPT
Dosage Form: SOLUTION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050517 Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 14-FEB-00
Trade Name: MEFOXIN
Dosage Form: INJECTABLE
Applicant: MERCK AND CO INC
Active Ingredient(s): CEFOXITIN
OTC/RX Status: RX

Application #: 020438 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 14-FEB-00
Trade Name: VESANOID
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 016295 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 12-FEB-00
Trade Name: HYDREA
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): HYDROXYUREA
OTC/RX Status: RX

Application #: 019514 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 11-FEB-00
Trade Name: IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE; POTASSIUM LACTATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC
OTC/RX Status: RX

Application #: 019513 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 11-FEB-00
Trade Name: IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC
OTC/RX Status: RX

Application #: 018896 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 11-FEB-00
Trade Name: POTASSIUM ACETATE IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): POTASSIUM ACETATE
OTC/RX Status: RX

Application #: 013025 Labeling Supplement#: 037
To Original New Drug Application
Approval Date: 11-FEB-00
Trade Name: THAM-E
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): TROMETHAMINE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
OTC/RX Status: RX

Application #: 050688 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 10-FEB-00
Trade Name: BANAN
Dosage Form: GRANULE, FOR RECONSTITUTION
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX

Application #: 050688 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 10-FEB-00
Trade Name: BANAN
Dosage Form: GRANULE, FOR RECONSTITUTION
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX

Application #: 050688 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 10-FEB-00
Trade Name: BANAN
Dosage Form: GRANULE, FOR RECONSTITUTION
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX

Application #: 050687 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 10-FEB-00
Trade Name: BANAN
Dosage Form: TABLET
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX

Application #: 050687 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 10-FEB-00
Trade Name: BANAN
Dosage Form: TABLET
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX

Application #: 050687 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 10-FEB-00
Trade Name: BANAN
Dosage Form: TABLET
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX

Application #: 020907 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 10-FEB-00
Trade Name: ACTIVELLE
Dosage Form: TABLET
Applicant: NOVO NORDISK PHARMACEUTICALS, INC
Active Ingredient(s): ESTRADIOL, NORTHINDRONE ACETATE
OTC/RX Status: RX

Application #: 018897 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 09-FEB-00
Trade Name: SODIUM CHLORIDE IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 018895 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 09-FEB-00
Trade Name: TPN ELECTROLYTES IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): SODIUM CHLORIDE; CALCIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM ACETATE
OTC/RX Status: RX

Application #: 017636 Labeling Supplement#: 047
To Original New Drug Application
Approval Date: 09-FEB-00
Trade Name: SORBITOL-MANNITOL IN PLASTIC CONTAINER
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): SORBITOL; MANNITOL
OTC/RX Status: RX

Application #: 020479 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 08-FEB-00
Trade Name: GASTROCROM
Dosage Form: SOLUTION
Applicant: MEDEVA PHARMACEUTICALS INC
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: RX

Application #: 019834 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 08-FEB-00
Trade Name: PLENDIL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ASTRAZENECA LP
Active Ingredient(s): FELODIPINE
OTC/RX Status: RX

Application #: 019194 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 08-FEB-00
Trade Name: SYPRINE
Dosage Form: CAPSULE
Applicant: MERCK AND CO INC
Active Ingredient(s): TRIENTINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020547 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 07-FEB-00
Trade Name: ACCOLATE
Dosage Form: TABLET
Applicant: ZENECA LTD
Active Ingredient(s): ZAFIRLUKAST
OTC/RX Status: RX

Application #: 050611 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 04-FEB-00
Trade Name: PCE
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): ERYTHROMYCIN
OTC/RX Status: RX

Application #: 050297 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 04-FEB-00
Trade Name: PEDIAMYCIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): ERYTHROMYCIN ETHYLSUCCINATE
OTC/RX Status: RX

Application #: 050207 Labeling Supplement#: 055
To Original New Drug Application
Approval Date: 04-FEB-00
Trade Name: E.E.S.
Dosage Form: GRANULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): ERYTHROMYCIN ETHYLSUCCINATE
OTC/RX Status: RX

Application #: 050207 Labeling Supplement#: 054
To Original New Drug Application
Approval Date: 04-FEB-00
Trade Name: E.E.S.
Dosage Form: GRANULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): ERYTHROMYCIN ETHYLSUCCINATE
OTC/RX Status: RX

Application #: 020847 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 04-FEB-00
Trade Name: ESCLIM
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: WOMEN FIRST HEALTHCARE INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Application #: 019297 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 04-FEB-00
Trade Name: NOVANTRONE
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): MITOXANTRONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018814 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 04-FEB-00
Trade Name: HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX

Application #: 020587 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 02-FEB-00
Trade Name: SCLEROSOL
Dosage Form: AEROSOL, METERED
Applicant: BRYAN CORP
Active Ingredient(s): TALC
OTC/RX Status: RX

Application #: 020312 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 02-FEB-00
Trade Name: UNIVASC
Dosage Form: TABLET
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): MOEXIPRIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019192 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 02-FEB-00
Trade Name: TRIPHASIL-21
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): LEVONORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 019190 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 02-FEB-00
Trade Name: TRIPHASIL-28
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): LEVONORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX