Drug Approvals for December 1996

Definitions and Notes

December 1996

Original New Drug Applications

Original Application #: 020681
Approval Date: 31-DEC-96
Trade Name: ORTHO TRI-CYCLEN
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE
OTC/RX Status: RX
Indication(s): Treatment of moderate acne vulgaris in females, greater or equal to 15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications

Original Application #: 020663
Approval Date: 31-DEC-96
Trade Name: MENTAX
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: PENEDERM INC
Active Ingredient(s): BUTENAFINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of tinea corporis and tinea cruris

Original Application #: 020656
Approval Date: 30-DEC-96
Trade Name: NUTROPIN
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: GENENTECH INC
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Indication(s): Treatment of growth failure associated with Turner Syndrome

Original Application #: 020593
Approval Date: 30-DEC-96
Trade Name: DEPACON
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): VALPROATE SODIUM
OTC/RX Status: RX
Indication(s): For temporary replacement therapy in various seizure disorders when oral therapy with valproic acid is not possible

Original Application #: 020668
Approval Date: 27-DEC-96
Trade Name: LEXXEL
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ASTRA MERCK INC
Active Ingredient(s): ENALAPRIL MALEATE; FELODIPINE
OTC/RX Status: RX
Indication(s): Treatment of hypertension

Original Application #: 020504
Approval Date: 27-DEC-96
Trade Name: MICROZIDE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Indication(s): For the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives

Original Application #: 020505
Approval Date: 24-DEC-96
Trade Name: TOPAMAX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): TOPIRAMATE
OTC/RX Status: RX
Indication(s): Adjunctive treatment for partial onset seizures in adults

Original Application #: 020486
Approval Date: 24-DEC-96
Trade Name: VANCERIL DOUBLE STRENGTH
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: AEROSOL, METERED
Applicant: SCHERING CORP
Active Ingredient(s): BECLOMETHASONE DIPROPIONATE
OTC/RX Status: RX
Indication(s): Maintenance treatment of asthma as prophylactic therapy

Original Application #: 020430
Approval Date: 24-DEC-96
Trade Name: ORGARAN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): DANAPAROID SODIUM
OTC/RX Status: RX
Indication(s): For the prophylaxis of post-operative deep venous thrombosis (DVT) which may lead to pulmonary embolism (PE) in patients undergoing elective hip replacement surgery

Original Application #: 020704
Approval Date: 23-DEC-96
Trade Name: CLARITIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SCHERING CORPORATION
Active Ingredient(s): LORATADINE
OTC/RX Status: RX
Indication(s): Treatment of nasal and non-nasal signs and symptoms of seasonal allergic rhinitis and the management of idiopathic chronic urticaria in patients 6 years of age and older

Original Application #: 020665
Approval Date: 23-DEC-96
Trade Name: DIOVAN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: CIBA GEIGY CORP
Active Ingredient(s): VALSARTAN
OTC/RX Status: RX
Indication(s): Treatment of hypertension

Original Application #: 020664
Approval Date: 23-DEC-96
Trade Name: DOSTINEX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CABERGOLINE
OTC/RX Status: RX
Indication(s): Treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas

Original Application #: 019931
Approval Date: 23-DEC-96
Trade Name: KLARON
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: LOTION
Applicant: DERMIK LABS
Active Ingredient(s): SODIUM SULFACETAMIDE
OTC/RX Status: RX
Indication(s): Treatment of acne vulgaris

Original Application #: 020655
Approval Date: 20-DEC-96
Trade Name: ALORA
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: THERATECH INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Indication(s): Treatment of moderate-to-severe vasomotor symptoms associated with the menopause, vulvar and vaginal atrophy, and hypoestrogenism due to hypogonadism, castration or primary ovarian failure

Original Application #: 020635
Approval Date: 20-DEC-96
Trade Name: LEVAQUIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): LEVOFLOXACIN
OTC/RX Status: RX
Indication(s): Acute maxillary sinusitis, acute bacterial exacerbations of chronic bronchitis, community-acquired pneumonia, uncomplicated skin and skin structure infections, complicated urinary tract infections, and acute pyelonephritis

Original Application #: 020634
Approval Date: 20-DEC-96
Trade Name: LEVAQUIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): LEVOFLOXACIN
OTC/RX Status: RX
Indication(s): Acute maxillary sinusitis, acute bacterial exacerbations of chronic bronchitis, community-acquired pneumonia, uncomplicated skin and skin structure infections, complicated urinary tract infections, and acute pyelonephritis

Original Application #: 020622
Approval Date: 20-DEC-96
Trade Name: COPAXONE
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: TEVA PHARMACEUTICALS USA
Active Ingredient(s): GLATIRAMER ACETATE
OTC/RX Status: RX
Indication(s): Reduction of relapses in patients with relapsing-remitting multiple sclerosis

Original Application #: 050717
Approval Date: 19-DEC-96
Trade Name: MONUROL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: GRANULE, FOR RECONSTITUTION
Applicant: ZAMBON CORP
Active Ingredient(s): FOSFOMYCIN TROMETHAMINE
OTC/RX Status: RX
Indication(s): Uncomplicated urinary tract infections(acute cystitis) in women due to suspectible strains of Escherichia coli and Enteroccus faecalis

Original Application #: 020677
Approval Date: 19-DEC-96
Trade Name: ZAGAM
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): SPARFLOXACIN
OTC/RX Status: RX
Indication(s): Community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, and acute maxillary sinusitis

Original Application #: 020688
Approval Date: 18-DEC-96
Trade Name: PATANOL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): OLOPATADINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the temporary prevention of itching of the eye due to allergic conjunctivitis

Original Application #: 020682
Approval Date: 18-DEC-96
Trade Name: GLYSET
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): MIGLITOL
OTC/RX Status: RX
Indication(s): An adjunct to diet or diet plus sulfonylurea therapy to improve glycemic control in patients with non-insulin-dependent diabetes mellitus (TYPE II)

Original Application #: 020702
Approval Date: 17-DEC-96
Trade Name: LIPITOR
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): ATORVASTATIN CALCIUM
OTC/RX Status: RX
Indication(s): An adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels in patients with primary hyperchloesterolemia (heterozygous familial and non familial) and mixed dyslipidemia (Fredrickson Types IIa and IIb); to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable

Original Application #: 020511
Approval Date: 17-DEC-96
Trade Name: APHTHASOL
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: PASTE
Applicant: BLOCK DRUG CO INC
Active Ingredient(s): AMLEXANOX
OTC/RX Status: RX
Indication(s): Treatment of signs and symptoms of aphthous ulcers in immunocompetent individuals

Original Application #: 020267
Approval Date: 13-DEC-96
Trade Name: JUNIOR STRENGTH ADVIL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: AMERICAN HOME PRODUCTS
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Indication(s): For the temporary reduction of fever and relief of minor aches and pains due to colds, flu, sore throat, headaches, and toothaches in children between ages 6 and 11 years old

Original Application #: 020580
Approval Date: 09-DEC-96
Trade Name: COTAZYM
Chemical Type: 7
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): PANCRELIPASE
OTC/RX Status: RX
Indication(s): Treatment of steatorrhea due to exocrine pancreatic enzyme deficiency in such conditions as cystic fibrosis and chronic pancreatitis

Original Application #: 020471
Approval Date: 09-DEC-96
Trade Name: ZYFLO
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): ZILEUTON
OTC/RX Status: RX
Indication(s): Prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older

Original Application #: 020694
Approval Date: 06-DEC-96
Trade Name: SPORANOX
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX
Indication(s): Treatment of onychomycosis of the fingernail without concomitant onychomycosis of the toenail with a pulse dosing regimen

Original Application #: 020410
Approval Date: 06-DEC-96
Trade Name: GASTROMARK
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: SUSPENSION
Applicant: ADVANCED MAGNETICS INC
Active Ingredient(s): FERUMOXSIL
OTC/RX Status: RX
Indication(s): Indicated in adult patients for oral use with magnetic resonance imaging to enhance the delineation of the bowel to distinguish it from organs and tissues that are adjacent to the upper regions of the gastrointestinal tract

Original Application #: 020417
Approval Date: 03-DEC-96
Trade Name: FEMPATCH
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Indication(s): Treatment of moderate to severe vasomotor symptoms associated with the menopause; vulvar and vaginal atrophy; hypoestrogenism due to hypogonadism, bilateral oophorectomy, or primary ovarian failure; abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology and only when associated with a hypoplastic or atrophic endometrium

Efficacy Supplemental New Drug Applications

Application #: 019700 EfficacySupplement#:007
Type: SE1 to Original New Drug Application
Approval Date: 31-DEC-96
Trade Name: ACULAR
Dosage Form: SOLUTION
Applicant: SYNTEX LABORATORIES INC SUB SYNTEX CORP
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX
Efficacy Claim: Treatment of postoperative inflammation in patients who have undergone cataract extraction

Application #: 018654 EfficacySupplement#:029
Type: SE2 to Original New Drug Application
Approval Date: 31-DEC-96
Trade Name: VERSED
Dosage Form: INJECTABLE
Applicant: HOFFMANN LAROCHE INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Continuous infusion for sedation of intubated mechanically ventilated patients

Application #: 050710 EfficacySupplement#:001
Type: SE5 to Original New Drug Application
Approval Date: 20-DEC-96
Trade Name: ZITHROMAX
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX
Efficacy Claim: Treatment of pediatric patients with mild to moderate community-aquired pneumonia due to Chlamidia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae

Application #: 050670 EfficacySupplement#:010
Type: SE5 to Original New Drug Application
Approval Date: 20-DEC-96
Trade Name: ZITHROMAX
Dosage Form: CAPSULE
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX
Efficacy Claim: Addition of Mycoplasma pneumoniae and Chlamydia pneumoniae to the community-acquired pneumonia indication

Application #: 050605 EfficacySupplement#:017
Type: SE1 to Original New Drug Application
Approval Date: 19-DEC-96
Trade Name: CEFTIN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX
Efficacy Claim: Addition of Early Lyme Disease to the indications and usage section of the labeling

Application #: 020087 EfficacySupplement#:017
Type: SE1 to Original New Drug Application
Approval Date: 19-DEC-96
Trade Name: FLOXIN
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX
Efficacy Claim: Pelvic inflammatory disease

Application #: 019735 EfficacySupplement#:042
Type: SE1 to Original New Drug Application
Approval Date: 19-DEC-96
Trade Name: FLOXIN
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX
Efficacy Claim: Pelvic inflammatory disease

Application #: 050605 Efficacy Supplement#:024
Type: SE1 to Original New Drug Application
Approval Date: 06-DEC-96
Trade Name: CEFTIN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX
Efficacy Claim: Addition of a single 1000mg oral dose in the treatment of uncomplicated gonorrhea (urethral and cervical) caused by penicillinase producing strains of Neisseria gonorrhoeae (PPNG) and rectal gonorrhea in females caused by non-penicillinase producing strains of Neisseria gonorrhoeae

Approvable Original New Drug Applications

Original Application #: 020742
Approvable Date: 31-DEC-96
Trade Name: BSS
Dosage Form: SOLUTION
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): SODIUM CHLORIDE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE DIHYYDRATE; MAGNESIUM CHLORIDE HEXAHYDRATE; SODIUM ACETATE TRIHYDRATE; SODIUM CITRATE DIHYDRATE; AND WATER FOR INJECTION
OTC/RX Status: RX

Original Application #: 020619
Approvable Date: 31-DEC-96
Trade Name: BETOPTIC PILO
Dosage Form: SUSPENSION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020600
Approvable Date: 30-DEC-96
Trade Name: TAZORAC
Dosage Form: GEL
Applicant: ALLERGAN INC
Active Ingredient(s): TAZAROTENE
OTC/RX Status: RX

Original Application #: 020667
Approvable Date: 23-DEC-96
Trade Name: MIRAPEX
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): PRAMIPEXOLE
OTC/RX Status: RX

Original Application #: 020441
Approvable Date: 23-DEC-96
Trade Name: PULMICORT
Dosage Form: POWDER
Applicant: ASTRA USA, INC
Active Ingredient(s): BUDESONIDE
OTC/RX Status: RX

Original Application #: 020686
Approvable Date: 18-DEC-96
Trade Name: LUMENHANCE
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: BRACCO DIAGNOSTICS INC
Active Ingredient(s): MANGANESE CHLORIDE TETRAHYDRATE
OTC/RX Status: RX

Original Application #: 020621
Approvable Date: 18-DEC-96
Trade Name: GADOLITE
Dosage Form: SUSPENSION
Applicant: PHARMACYCLICS INC
Active Ingredient(s): GADOLINIUM CHLORIDE HEXAHYDRATE
OTC/RX Status: RX

Original Application #: 020681
Approvable Date: 06-DEC-96
Trade Name: ORTHO TRI-CYCLEN
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE
OTC/RX Status: RX

Original Application #: 020648
Approvable Date: 02-DEC-96
Trade Name: DIASTAT
Dosage Form: GEL
Applicant: ATHENA NEUROSCIENCES INC
Active Ingredient(s): DIAZEPAM
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074799
Approval Date: 31-DEC-96
Trade Name: FLUOCINONIDE
Dosage Form: SOLUTION
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): FLUOCINONIDE
OTC/RX Status: RX

Original Abbreviated Application # 074694
Approval Date: 31-DEC-96
Trade Name: CLOMIPRAMINE HCL
Dosage Form: CAPSULE
Applicant: TARO PHARMACEUTICAL INDUSTRIES LTD
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074654
Approval Date: 31-DEC-96
Trade Name: ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
OTC/RX Status: RX

Original Abbreviated Application # 074035
Approval Date: 31-DEC-96
Trade Name: KETOPROFEN
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): KETOPROFEN
OTC/RX Status: RX

Original Abbreviated Application # 074731
Approval Date: 24-DEC-96
Trade Name: MINOXIDIL
Dosage Form: SOLUTION
Applicant: HI TECH PHARMACAL CO INC
Active Ingredient(s): MINOXIDIL
OTC/RX Status: OTC

Original Abbreviated Application # 074633
Approval Date: 23-DEC-96
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX

Original Abbreviated Application # 074632
Approval Date: 23-DEC-96
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064141
Approval Date: 23-DEC-96
Trade Name: AMPHOTERICIN B
Dosage Form: INJECTABLE
Applicant: SANOFI WINTHROP INC
Active Ingredient(s): AMPHOTERICIN B
OTC/RX Status: RX

Original Abbreviated Application # 074792
Approval Date: 19-DEC-96
Trade Name: GLYBURIDE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064031
Approval Date: 19-DEC-96
Trade Name: AMOXICILLIN
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): AMOXICILLIN
OTC/RX Status: RX

Original Abbreviated Application # 040139
Approval Date: 16-DEC-96
Trade Name: PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): PROPOXYPHENE HYDROCHLORIDE; ACETAMINOPHEN
OTC/RX Status: RX

Original Abbreviated Application # 040111
Approval Date: 13-DEC-96
Trade Name: PROCAINAMIDE HCL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): PROCAINAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040103
Approval Date: 12-DEC-96
Trade Name: BENZTROPINE MESYLATE
Dosage Form: TABLET
Applicant: ROSEMONT PHARMACEUTICAL CORP
Active Ingredient(s): BENZTROPINE MESYLATE
OTC/RX Status: RX

Original Abbreviated Application # 074534
Approval Date: 11-DEC-96
Trade Name: SUFENTANIL CITRATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): SUFENTANIL CITRATE
OTC/RX Status: RX

Original Abbreviated Application # 074734
Approval Date: 10-DEC-96
Trade Name: IOPAMIDOL
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX

Original Abbreviated Application # 074644
Approval Date: 10-DEC-96
Trade Name: METOPROLOL TARTRATE
Dosage Form: TABLET
Applicant: CARACO PHARMACEUTICAL LABORATORIES LTD
Active Ingredient(s): METOPROLOL TARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 074439
Approval Date: 10-DEC-96
Trade Name: NICARDIPINE HCL
Dosage Form: CAPSULE
Applicant: ZENITH LABORATORIES INC
Active Ingredient(s): NICARDIPINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040152
Approval Date: 03-DEC-96
Trade Name: CARISOPRODOL
Dosage Form: TABLET
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): CARISOPRODOL
OTC/RX Status: RX

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

Application #: 074639
Tentative Approval Date : 13-DEC-96
Drug Name: ATRACURIUM BESYLATE
Applicant: ABBOTT LABORATORIES DIAGNOSTICS DIV

Application #: 074633
Tentative Approval Date : 13-DEC-96
Drug Name: ATRACURIUM BESYLATE
Applicant: ABBOTT LABORATORIES DIAGNOSTICS DIV

Application #: 074632
Tentative Approval Date : 13-DEC-96
Drug Name: ATRACURIUM BESYLATE
Applicant: ABBOTT LABORATORIES DIAGNOSTICS DIV

Application #: 074646
Tentative Approval Date : 10-DEC-96
Drug Name: NAPROXEN SODIUM
Applicant: INVAMED INC

Application #: 074819
Tentative Approval Date : 03-DEC-96
Drug Name: ETODOLAC
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC

Labeling Supplements to Original New Drug Applications

Application #: 020545 Labeling Supplement#:001 To Original New Drug Application
Approval Date: 30-DEC-96
Trade Name: PROCANBID
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): PROCAINAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050549 Labeling Supplement#:020 To Original New Drug Application
Approval Date: 26-DEC-96
Trade Name: MEZLIN
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): MEZLOCILLIN SODIUM MONOHYDRATE
OTC/RX Status: RX

Application #: 020450 Labeling Supplement#:001 To Original New Drug Application
Approval Date: 26-DEC-96
Trade Name: CEREBYX
Dosage Form: INJECTABLE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): FOSPHENYTOIN SODIUM
OTC/RX Status: RX

Application #: 050646 Labeling Supplement#:011 To Original New Drug Application
Approval Date: 24-DEC-96
Trade Name: CEPTAZ
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME (L-ARGININE FORMULATION)
OTC/RX Status: RX

Application #: 050634 Labeling Supplement#:010 To Original New Drug Application
Approval Date: 24-DEC-96
Trade Name: FORTAZ
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME SODIUM
OTC/RX Status: RX

Application #: 050578 Labeling Supplement#:037 To Original New Drug Application
Approval Date: 24-DEC-96
Trade Name: FORTAZ
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME
OTC/RX Status: RX

Application #: 020406 Labeling Supplement#:012 To Original New Drug Application
Approval Date: 24-DEC-96
Trade Name: PREVACID
Dosage Form: CAPSULE, DELAYED RELEASE GRANULES
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX

Application #: 050672 Labeling Supplement#:009 To Original New Drug Application
Approval Date: 23-DEC-96
Trade Name: CEFTIN
Dosage Form: POWDER FOR RECONSTITUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX

Application #: 050672 Labeling Supplement#:004 To Original New Drug Application
Approval Date: 23-DEC-96
Trade Name: CEFTIN
Dosage Form: POWDER FOR RECONSTITUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX

Application #: 050643 Labeling Supplement#:009 To Original New Drug Application
Approval Date: 23-DEC-96
Trade Name: ZINACEF
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX

Application #: 050643 Labeling Supplement#:007 To Original New Drug Application
Approval Date: 23-DEC-96
Trade Name: ZINACEF
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX

Application #: 050605 Labeling Supplement#:026 To Original New Drug Application
Approval Date: 23-DEC-96
Trade Name: CEFTIN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX

Application #: 050596 Labeling Supplement#:020 To Original New Drug Application
Approval Date: 23-DEC-96
Trade Name: CLAFORAN IN SODIUM CHLORIDE 0.9%
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): CEFOTAXIME SODIUM
OTC/RX Status: RX

Application #: 050558 Labeling Supplement#:047 To Original New Drug Application
Approval Date: 23-DEC-96
Trade Name: ZINACEF
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX

Application #: 050558 Labeling Supplement#:044 To Original New Drug Application
Approval Date: 23-DEC-96
Trade Name: ZINACEF
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX

Application #: 050547 Labeling Supplement#:044 To Original New Drug Application
Approval Date: 23-DEC-96
Trade Name: CLAFORAN
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): CEFOTAXIME SODIUM
OTC/RX Status: RX

Application #: 020080 Labeling Supplement#: 005 To Original New Drug Application
Approval Date: 23-DEC-96
Trade Name: IMITREX >
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME
Active Ingredient(s): SUMATRIPTAN SUCCINATE
OTC/RX Status: RX

Application #: 050662 Labeling Supplement#: 013 To Original New Drug Application
Approval Date: 20-DEC-96
Trade Name: BIAXIN >
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX

Application #: 018276 Labeling Supplement#: 033 To Original New Drug Application
Approval Date: 20-DEC-96
Trade Name: XANAX
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ALPRAZOLAM
OTC/RX Status: RX

Application #: 012665 Labeling Supplement#: 031 To Original New Drug Application
Approval Date: 20-DEC-96
Trade Name: VELBAN
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): VINBLASTINE SULFATE
OTC/RX Status: RX

Application #: 020482 Labeling Supplement#: 003 To Original New Drug Application
Approval Date: 13-DEC-96
Trade Name: PRECOSE
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): ACARBOSE
OTC/RX Status: RX

Application #: 020121 Labeling Supplement#: 004 To Original New Drug Application
Approval Date: 12-DEC-96
Trade Name: FLONASE
Dosage Form: SPRAY, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX

Application #: 017060 Labeling Supplement #: 063 To Original New Drug Application
Approval Date: 11-DEC-96
Trade Name: NOR-QD
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): NORETHINDRONE
OTC/RX Status: RX

Application #: 020083 Labeling Supplement #: 017 To Original New Drug Application
Approval Date: 10-DEC-96
Trade Name: SPORANOX
Dosage Form: CAPSULE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Application #: 020553 Labeling Supplement#: 002 To Original New Drug Application
Approval Date: 09-DEC-96
Trade Name: OXYCONTIN
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PURDUE PHARMA
Active Ingredient(s): OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019764 Labeling Supplement#: 001 To Original New Drug Application
Approval Date: 09-DEC-96
Trade Name: SAIZEN
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX

Application #: 020560 Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 03-DEC-96
Trade Name: FOSAMAX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX

Application #: 019085 Labeling Supplement#: 014 To Original New Drug Application
Approval Date: 03-DEC-96
Trade Name: ATROVENT
Dosage Form: AEROSOL, METERED
Applicant: BOEHRINGER INGELHEIM
Active Ingredient(s): IPRATROPIUM BROMIDE
OTC/RX Status: RX