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Drug Approvals for September 1996

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Definitions and Notes

Original New Drug Applications


Original Application #: 020592
Approval Date: 30-SEP-96
Trade Name: ZYPREXA
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): OLANZAPINE
OTC/RX Status: RX
Indication(s): MANAGEMENT OF THE MANIFESTATIONS OF PSYCHOTIC DISORDERS


Original Application #: 020577
Approval Date: 27-SEP-96
Trade Name: ELLIOTTS B SOLUTION
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: ORPHAN MEDICAL INC
Active Ingredient(s): CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC
OTC/RX Status: RX
Indication(s): Use as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma


Original Application #: 020346
Approval Date: 27-SEP-96
Trade Name: ZYRTEC
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SYRUP
Applicant: PFIZER INC
Active Ingredient(s): CETIRIZINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): SEASONAL AND PERENNIAL ALLERGIC RHINITIS, CHRONIC IDIOPATHIC URTICARIA


Original Application #: 020547
Approval Date: 26-SEP-96
Trade Name: ACCOLATE
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ZENECA LTD
Active Ingredient(s): ZAFIRLUKAST
OTC/RX Status: RX
Indication(s): PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER


Original Application #: 020193
Approval Date: 26-SEP-96
Trade Name: ELMIRON
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: BAKER NORTON PHARMACEUTICALS INC
Active Ingredient(s): PENTOSAN POLYSULFATE SODIUM
OTC/RX Status: RX
Indication(s): RELIEF OF BLADDER PAIN OR DISCOMFORT ASSOCIATED WITH INTERSTITIAL CYSTITIS


Original Application #: 020629
Approval Date: 24-SEP-96
Trade Name: DENAVIR
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PENCICLOVIR
OTC/RX Status: RX
Indication(s): TREATMENT OF HERPES LABIALIS IN ADULTS


Original Application #: 020533
Approval Date: 24-SEP-96
Trade Name: NAROPIN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ASTRA USA INC
Active Ingredient(s): ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
OTC/RX Status: RX
Indication(s): Production of local or regional anesthesia for surgery, for postoperative pain management and for obstetrical procedures


Original Application #: 020637
Approval Date: 23-SEP-96
Trade Name: GLIADEL
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: IMPLANT
Applicant: GUILFORD PHARMACEUTICALS INC
Active Ingredient(s): CARMUSTINE
OTC/RX Status: RX
Indication(s): FOR USE AS AN ADJUNCT TO SURGERY TO PROLONG SURVIVAL IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME FOR WHOM SURGICAL RESECTION IS INDICATED


Original Application #: 020169
Approval Date: 19-SEP-96
Trade Name: NILANDRON
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: GH BESSELAAR ASSOC INC
Active Ingredient(s): NILUTAMIDE
OTC/RX Status: RX
Indication(s): FOR USE IN COMBINATION WITH SURGICAL CASTRATION FOR THE TREATMENT OF STAGE D2 METASTATIC PROSTATE CANCER


Original Application #: 020586
Approval Date: 17-SEP-96
Trade Name: MERETEK BREATH TEST
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: POWDER FOR RECONSTITUTION
Applicant: MERETEK DIAGNOSTICS INC
Active Ingredient(s): UREA, C-13
OTC/RX Status: RX
Indication(s): DRUG/DIAGNOSTIC DEVICE FOR DETECTION OF H PYLORI ASSOCIATED UREASE


Original Application #: 020613
Approval Date: 06-SEP-96
Trade Name: ALPHAGAN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: SOLUTION/DROPS
Applicant: ALLERGAN INC
Active Ingredient(s): BRIMONIDINE TARTRATE
OTC/RX Status: RX
Indication(s): EFFECTIVE FOR LOWERING INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION


Original Application #: 019815
Approval Date: 06-SEP-96
Trade Name: PROAMATINE
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: ROBERTS LABORATORIES INC
Active Ingredient(s): MIDODRINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): TREATMENT OF SYMPTOMATIC ORTHOSTATIC HYPOTENSION

Efficacy Supplemental New Drug Applications


Application #: 050547; Efficacy Supplement #: 042
Type: SE2 to Original New Drug Application
Approval Date: 27-SEP-96
Trade Name: CLAFORAN
Dosage Form: INJECTABLE
Applicant: HOECHST ROUSSEL PHARMACEUTICALS INC
Active Ingredient(s): CEFOTAXIME SODIUM
OTC/RX Status: RX
Efficacy Claim: 500mg IM single dose for the treatment of uncomplicated gonorrhea caused by Neisseria gonorrhoeae


Application #: 019700; Efficacy Supplement #: 003
Type: SE2 to Original New Drug Application
Approval Date: 18-SEP-96
Trade Name: ACULAR
Dosage Form: SOLUTION/DROPS
Applicant: HOFFMAN-LAROCHE
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX
Efficacy Claim: EXTENSION OF THE DOSING PERIOD BEYOND ONE WEEK OF THERAPY


Application #: 019537; Efficacy Supplement #: 021
Type: SE1 to Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: CIPRO
Dosage Form: TABLET
Applicant: BAYER CORP
Acts)e Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: CHRONIC BACTERIAL PROSTATITIS


Application #: 050665; Efficacy Supplement #: 013
Type: SE1 to Original New Drug Application
Approval Date: 05-SEP-96
Trade Name: CEFZIL
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFPROZIL
OTC/RX Status: RX
Efficacy Claim: PROVIDE INFORMATION IN SUPPORT OF THE ADDITION OF ACUTE SINUSITIS CAUSED BY S. PNEUMONIAE, S. AUREUS, H. INFLUENZAE, AND M. CATARRHALIS TO THE INDICATIONS AND USAGE SECTION


Application #: 050664; Efficacy Supplement #: 014
Type: SE1 to Original New Drug Application
Approval Date: 05-SEP-96
Trade Name: CEFZIL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFPROZIL
OTC/RX Status: RX
Efficacy Claim: PROVIDE INFORMATION IN SUPPORT OF THE ADDITION OF ACUTE SINUSITIS CAUSED BY S. PNEUMONIAE, S. AUREUS, H. INFLUENZAE, AND M. CATARRHALIS TO THE INDICATIONS AND USAGE SECTION

Approvable Original New Drug Applications


Original Application #: 020535
Approvable Date: 30-SEP-96
Trade Name: DURACT
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): BROMFENAC SODIUM
OTC/RX Status: RX


Original Application #: 020690
Approvable Date: 19-SEP-96
Trade Name: ARICEPT
Dosage Form: TABLET
Applicant: EISAI AMERICA INC
Active Ingredient(s): DONEPEZIL HYDROCHLORIDE
OTC/RX Status: RX


Original Application #: 020687
Approvable Date: 18-SEP-96
Trade Name: MIFEPRISTONE
Dosage Form: TABLET
Applicant: THE POPULATION COUNCIL
Active Ingredient(s): MIFEPRISTONE
OTC/RX Status: RX


Original Application #: 020267
Approvable Date: 14-SEP-96
Trade Name: JUNIOR STRENGTH ADVIL
Dosage Form: TABLET
Applicant: AMERICAN HOME PRODUCTS
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC


Original Application #: 020652
Approvable Date: 12-SEP-96
Trade Name: TESLASCAN
Dosage Form: INJECTION
Applicant: NYCOMED INC
Active Ingredient(s): MANGAFODIPIR TRISODIUM
OTC/RX Status: RX


Original Application #: 020537
Approvable Date: 09-SEP-96
Trade Name: SPORANOX
Dosage Form: CAPSULE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX


Original Application #: 020231
Approvable Date: 05-SEP-96
Trade Name: TOTAL TOOTHPASTE
Dosage Form: DENTIFRICE
Applicant: COLGATE PALMOLIVE CO
Active Ingredient(s): TRICLOSAN; SODIUM FLUORIDE
OTC/RX Status: OTC

Original Abbreviated New Drug Applications


Original Abbreviated Application # 074392
Approval Date: 30-SEP-96
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: CREAM
Applicant: E FOUGERA DIV ALTANA INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX


Original Abbreviated Antibiotic Application # 064136
Approval Date: 30-SEP-96
Trade Name: CLINDETS
Dosage Form: SWAB
Applicant: STIEFEL LABORATORIES INC
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX


Original Abbreviated Antibiotic Application # 064108
Approval Date: 27-SEP-96
Trade Name: CLINDAMYCIN PHOSPHATE
Dosage Form: SOLUTION
Applicant: STIEFEL LABORATORIES INC
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX


Original Abbreviated Application # 074610
Approval Date: 26-SEP-96
Trade Name: CIMETIDINE HCL
Dosage Form: SOLUTION
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
OTC/RX Status: RX


Original Abbreviated Application # 074585
Approval Date: 26-SEP-96
Trade Name: INDAPAMINE
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): INDAPAMIDE
OTC/RX Status: RX


Original Abbreviated Application # 074381
Approval Date: 26-SEP-96
Trade Name: DOBUTAMINE HCL
Dosage Form: INJECTABLE
Applicant: ELKINS SINN DIV AH ROBINS CO INC
Active Ingredient(s): DOBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX


Original Abbreviated Application # 040117
Approval Date: 23-SEP-96
Trade Name: HYDROCODONE BITARTRATE & ACETAMINOPHEN
Dosage Form: TABLET
Applicant: KNOLL PHARMACEUTICAL CO SUB BASF CORP
Active Ingredient(s): HYDROCODONE BITARTRATE; ACETAMINOPHEN
OTC/RX Status: RX


Original Abbreviated Application # 040098
Approval Date: 20-SEP-96
Trade Name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Dosage Form: SOLUTION
Applicant: MOVA PHARMACEUTICALS CORP
Active Ingredient(s): ACETAMINOPHEN; CODEINE PHOSPHATE
OTC/RX Status: RX


Original Abbreviated Application # 040167
Approval Date: 18-SEP-96
Trade Name: DOXYLAMINE SUCCINATE
Dosage Form: TABLET
Applicant: L PERRIGO CO
Active Ingredient(s): DOXYLAMINE SUCCINATE
OTC/RX Status: OTC


Original Abbreviated Application # 074725
Approval Date: 16-SEP-96
Trade Name: FLUPHENAZINE HCL
Dosage Form: CONCENTRATE
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): FLUPHENAZINE HYDROCHLORIDE
OTC/RX Status: RX


Original Abbreviated Antibiotic Application # 064081
Approval Date: 16-SEP-96
Trade Name: CEFACLOR
Dosage Form: CAPSULE
Applicant: BIOCRAFT LABORATORIES INC
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX


Original Abbreviated Application # 074551
Approval Date: 12-SEP-96
Trade Name: LORAZEPAM
Dosage Form: INJECTABLE
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): LORAZEPAM
OTC/RX Status: RX


Original Abbreviated Application # 074535
Approval Date: 12-SEP-96
Trade Name: LORAZEPAM
Dosage Form: INJECTABLE
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): LORAZEPAM
OTC/RX Status: RX


Original Abbreviated Antibiotic Application # 063342
Approval Date: 12-SEP-96
Trade Name: DOXORUBICIN HCL
Dosage Form: BULK
Applicant: HAIMEN PHARMACEUTICAL FACTORY
Active Ingredient(s): DOXORUBICIN HYDROCHLORIDE
OTC/RX Status: RX


Original Abbreviated Application # 074795
Approval Date: 10-SEP-96
Trade Name: FLUPHENAZINE DECANOATE
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): FLUPHENAZINE DECANOATE
OTC/RX Status: RX


Original Abbreviated Application # 074569
Approval Date: 10-SEP-96
Trade Name: CLONAZEPAM
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX

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



Original Abbreviated Application #: 074596
Tentative Approval Date: 10-SEP-96
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications


Application #: 050522; Labeling Supplement #: 014 To Original New Drug Application
Approval Date: 30-SEP-96
Trade Name: CECLOR
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX


Application #: 050521; Labeling Supplement #: 018 To Original New Drug Application
Approval Date: 30-SEP-96
Trade Name: CECLOR
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX


Application #: 050592; Labeling Supplement #: 014 To Original New Drug Application
Approval Date: 27-SEP-96
Trade Name: TOBRADEX
Dosage Form: SUSPENSION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): DEXAMETHASONE; TOBRAMYCIN
OTC/RX Status: RX


Application #: 050592; Labeling Supplement #: 013 To Original New Drug Application
Approval Date: 27-SEP-96
Trade Name: TOBRADEX
Dosage Form: SUSPENSION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): DEXAMETHASONE; TOBRAMYCIN
OTC/RX Status: RX


Application #: 020628; Labeling Supplement #: 004 To Original New Drug Application
Approval Date: 27-SEP-96
Trade Name: INVIRASE
Dosage Form: CAPSULE
Applicant: HOFFMANN LAROCHE INC
Active Ingredient(s): SAQUINAVIR MESYLATE
OTC/RX Status: RX


Application #: 020237; Labeling Supplement #: 005 To Original New Drug Application
Approval Date: 27-SEP-96
Trade Name: SALAGEN
Dosage Form: TABLET
Applicant: MGI PHARMA INC
Active Ingredient(s): PILOCARPINE HYDROCHLORIDE
OTC/RX Status: RX


Application #: 020013; Labeling Supplement #: 006 To Original New Drug Application
Approval Date: 27-SEP-96
Trade Name: MAXAQUIN
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): LOMEFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX


Application #: 050616; Labeling Supplement #: 009 To Original New Drug Application
Approval Date: 26-SEP-96
Trade Name: TOBRADEX
Dosage Form: OINTMENT
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): TOBRAMYCIN; DEXAMETHASONE
OTC/RX Status: RX


Application #: 020485; Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 26-SEP-96
Trade Name: OCUHIST
Dosage Form: SOLUTION/ DROPS
Applicant: AKORN INC
Active Ingredient(s): PHENIRAMINE MALEATE; NAPHAZOLINE HYDROCHLORIDE
OTC/RX Status: OTC


Application #: 020226; Labeling Supplement #: 007 To Original New Drug Application
Approval Date: 26-SEP-96
Trade Name: NAPHCON-A
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
OTC/RX Status: OTC


Application #: 019079; Labeling Supplement #: 009 To Original New Drug Application
Approval Date: 26-SEP-96
Trade Name: FLAREX
Dosage Form: SUSPENSION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): FLUOROMETHOLONE ACETATE
OTC/RX Status: RX


Application #: 013422; Labeling Supplement #: 024 To Original New Drug Application
Approval Date: 26-SEP-96
Trade Name: MAXIDEX
Dosage Form: SUSPENSION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): DEXAMETHASONE
OTC/RX Status: RX


Application #: 012015; Labeling Supplement #: 021 To Original New Drug Application
Approval Date: 26-SEP-96
Trade Name: COGENTIN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): BENZTROPINE MESYLATE
OTC/RX Status: RX


Application #: 009193; Labeling Supplement #: 034 To Original New Drug Application
Approval Date: 26-SEP-96
Trade Name: COGENTIN
Dosage Form: TABLET
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): BENZTROPINE MESYLATE
OTC/RX Status: RX


Application #: 008922; Labeling Supplement #: 014 To Original New Drug Application
Approval Date: 26-SEP-96
Trade Name: CALCIUM DISODIUM VERSENATE
Dosage Form: INJECTABLE
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): EDETATE CALCIUM DISODIUM
OTC/RX Status: RX


Application #: 050596; Labeling Supplement #: 010 To Original New Drug Application
Approval Date: 24-SEP-96
Trade Name: CLAFORAN IN SODIUM CHLORIDE 0.9%
Dosage Form: INJECTABLE
Applicant: HOECHST ROUSSEL PHARMACEUTICALS INC
Active Ingredient(s): CEFOTAXIME SODIUM
OTC/RX Status: RX


Application #: 050547; Labeling Supplement #: 015 To Original New Drug Application
Approval Date: 24-SEP-96
Trade Name: CLAFORAN
Dosage Form: INJECTABLE
Applicant: HOECHST ROUSSEL PHARMACEUTICALS INC
Active Ingredient(s): CEFOTAXIME SODIUM
OTC/RX Status: RX


Application #: 050522; Labeling Supplement #: 017 To Original New Drug Application
Approval Date: 24-SEP-96
Trade Name: CECLOR
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX


Application #: 050521; Labeling Supplement #: 020 To Original New Drug Application
Approval Date: 24-SEP-96
Trade Name: CECLOR
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX


Application #: 020680; Labeling Supplement #: 004 To Original New Drug Application
Approval Date: 24-SEP-96
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX


Application #: 020659; Labeling Supplement #: 004 To Original New Drug Application
Approval Date: 24-SEP-96
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX


Application #: 020287; Labeling Supplement #: 005 To Original New Drug Application
Approval Date: 24-SEP-96
Trade Name: FRAGMIN
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): DALTEPARIN SODIUM
OTC/RX Status: RX


Application #: 016295; Labeling Supplement #: 023 To Original New Drug Application
Approval Date: 24-SEP-96
Trade Name: HYDREA
Dosage Form: CAPSULE
Applicant: ER SQUIBB AND SONS INC
Active Ingredient(s): HYDROXYUREA
OTC/RX Status: RX


Application #: 016295; Labeling Supplement #: 011 To Original New Drug Application
Approval Date: 24-SEP-96
Trade Name: HYDREA
Dosage Form: CAPSULE
Applicant: ER SQUIBB AND SONS INC
Active Ingredient(s): HYDROXYUREA
OTC/RX Status: RX


Application #: 019835; Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 23-SEP-96
Trade Name: ZYRTEC
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): CETIRIZINE HYDROCHLORIDE
OTC/RX Status: RX


Application #: 018830; Labeling Supplement #: 018 To Original New Drug Application
Approval Date: 20-SEP-96
Trade Name: TAMBOCOR
Dosage Form: TABLET
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): FLECAINIDE ACETATE
OTC/RX Status: RX


Application #: 020347; Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 18-SEP-96
Trade Name: HYTRIN
Dosage Form: CAPSULE, COATED, SOFT GELATIN
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX


Application #: 019700; Labeling Supplement #: 004 To Original New Drug Application
Approval Date: 18-SEP-96
Trade Name: ACULAR
Dosage Form: SOLUTION/DROPS
Applicant: HOFFMAN-LAROCHE
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX


Application #: 019057; Labeling Supplement #: 011 To Original New Drug Application
Approval Date: 18-SEP-96
Trade Name: HYTRIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX


Application #: 050627; Labeling Supplement #: 004 To Original New Drug Application
Approval Date: 17-SEP-96
Trade Name: RIFADIN
Dosage Form: INJECTION
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): RIFAMPIN
OTC/RX Status: RX


Application #: 050420; Labeling Supplement #: 067 To Original New Drug Application
Approval Date: 17-SEP-96
Trade Name: RIFADIN
Dosage Form: CAPSULE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): RIFAMPIN
OTC/RX Status: RX


Application #: 018814 Labeling Supplement #: 022 To Original New Drug Application
Approval Date: 17-SEP-96
Trade Name: HEPARIN SODIUM IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX


Application #: 018609 Labeling Supplement #: 031 To Original New Drug Application
Approval Date: 17-SEP-96
Trade Name: HEPARIN SODIUM IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form: INJECTION
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX


Application #: 050672 Labeling Supplement #: 005 To Original New Drug Application
Approval Date: 13-SEP-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 #: 001 To Original New Drug Application
Approval Date: 13-SEP-96
Trade Name: CEFTIN
Dosage Form: POWDER FOR RECONSTITUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX


Application #: 050605 Labeling Supplement #: 023 To Original New Drug Application
Approval Date: 13-SEP-96
Trade Name: CEFTIN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX


Application #: 050605 Labeling Supplement #: 022 To Original New Drug Application
Approval Date: 13-SEP-96
Trade Name: CEFTIN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX


Application #: 019668 Labeling Supplement #: 008 To Original New Drug Application
Approval Date: 13-SEP-96
Trade Name: CARDURA
Dosage Form: TABLET
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX


Application #: 017584 Labeling Supplement #: 028 To Original New Drug Application
Approval Date: 13-SEP-96
Trade Name: LIDOCAINE HCL
Dosage Form: INJECTABLE
Applicant: FUJISAWA USA INC
Active Ingredient(s): LIDOCAINE HYDROCHLORIDE
OTC/RX Status: RX </2


Application #: 050587 Labeling Supplement #: 039 To Original New Drug Application
Approval Date: 12-SEP-96
Trade Name: PRIMAXIN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): IMIPENEM; CILASTATIN SODIUM
OTC/RX Status: RX


Application #: 020011 Labeling Supplement #: 010 To Original New Drug Application
Approval Date: 12-SEP-96
Trade Name: LUPRON DEPOT
Dosage Form: INJECTABLE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX


Application #: 019943 Labeling Supplement #: 006 To Original New Drug Application
Approval Date: 12-SEP-96
Trade Name: LUPRON DEPOT
Dosage Form: INJECTABLE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX


Application #: 019658 Labeling Supplement #: 001 To Original New Drug Application
Approval Date: 12-SEP-96
Trade Name: CLARITIN
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): LORATADINE
OTC/RX Status: RX


Application #: 019384 Labeling Supplement #: 029 To Original New Drug Application
Approval Date: 12-SEP-96
Trade Name: NOROXIN
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): NORFLOXACIN
OTC/RX Status: RX


Application #: 050646 Labeling Supplement #: 006 To Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: CEPTAZ
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME (ARGININE FORMULATION)
OTC/RX Status: RX


Application #: 050643 Labeling Supplement #: 008 To Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: ZINACEF
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX


Application #: 050634 Labeling Supplement #: 009 To Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: FORTAZ
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME SODIUM
OTC/RX Status: RX


Application #: 050578 Labeling Supplement #: 030 To Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: FORTAZ
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME
OTC/RX Status: RX


Application #: 050558 Labeling Supplement #: 045 To Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: ZINACEF
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX


Application #: 020087 Labeling Supplement #: 015 To Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: FLOXIN IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX


Application #: 020057 Labeling Supplement #: 031 To Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: CEREDASE
Dosage Form: INJECTABLE
Applicant: GENZYME CORP
Active Ingredient(s): ALGLUCERASE
OTC/RX Status: RX


Application #: 020013 Labeling Supplement #: 010 To Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: MAXAQUIN
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): LOMEFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX


Application #: 019735 Labeling Supplement #: 038 To Original New Drug Application
Approval Date: 11-SEP-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


Application #: 018452 Labeling Supplement #: 021 To Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: SEPTRA
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX


Application #: 017598 Labeling Supplement #: 033 To Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: SEPTRA
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX


Application #: 017376 Labeling Supplement #: 048 To Original New Drug Application
Approval Date: 11-SEP-96
Trade Name: SEPTRA
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX

Application #: 007961 Labeling Supplement #: 024 To Original New Drug Application
Approval Date: 09-SEP-96
Trade Name: BENTYL
Dosage Form: SYRUP
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
OTC/RX Status: RX


Application #: 007409 Labeling Supplement #: 038 To Original New Drug Application
Approval Date: 09-SEP-96
Trade Name: BENTYL
Dosage Form: CAPSULE; TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
OTC/RX Status: RX


Application #: 018891 Labeling Supplement #: 016 To Original New Drug Application
Approval Date: 06-SEP-96
Trade Name: CATAPRES-TTS
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): CLONIDINE
OTC/RX Status: RX


Application #: 018891 Labeling Supplement #: 015 To Original New Drug Application
Approval Date: 06-SEP-96
Trade Name: CATAPRES-TTS
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): CLONIDINE
OTC/RX Status: RX


Application #: 008370 Labeling Supplement #: 027 To Original New Drug Application
Approval Date: 06-SEP-96
Trade Name: BENTYL
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
OTC/RX Status: RX


Application #: 009218 Labeling Supplement #: 085 To Original New Drug Application
Approval Date: 05-SEP-96
Trade Name: COUMADIN
Dosage Form: TABLET
Applicant: DUPONT MERCK PHARMACEUTICAL CO
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX


Application #: 018649 Labeling Supplement #: 034 To Original New Drug Application
Approval Date: 04-SEP-96
Trade Name: THEOPHYLLINE AND DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): THEOPHYLLINE
OTC/RX Status: RX


Application #: 019901 Labeling Supplement #: 019 To Original New Drug Application
Approval Date: 03-SEP-96
Trade Name: ALTACE
Dosage Form: CAPSULE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): RAMIPRIL
OTC/RX Status: RX


Application #: 019778 Labeling Supplement #: 012 To Original New Drug Application
Approval Date: 03-SEP-96
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 #: 035 To Original New Drug Application
Approval Date: 03-SEP-96
Trade Name: PRINIVIL
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX


Application #: 019558 Labeling Supplement #: 019 To Original New Drug Application
Approval Date: 03-SEP-96
Trade Name: PRINIVIL
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

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October 18, 1996 http://www.fda.gov/cder/da/da996.htm