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Drug Approvals for April 1997

Drug Approvals for April 1997

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Definitions and Notes

April 1997

Original New Drug Applications


Original Application #: 020619
Approval Date: 17-APR-97
Trade Name: BETOPTIC PILO
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: SUSPENSION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma and ocular hyprtension who are insufficiently responsive to Betoptic-S (Failed to achieve target IOP determined after multiple measurements over time)


Original Application #: 020579
Approval Date: 15-APR-97
Trade Name: FLOMAX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): TAMSULOSIN HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)

Original Application #: 020705
Approval Date: 04-APR-97
Trade Name: RESCRIPTOR
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): DELAVIRDINE MESYLATE
OTC/RX Status: RX
Indication(s): Treatment of HIV-1 infection in combination with appropriate antiretroviral agents when therapy is warranted

 

Efficacy Supplemental New Drug Applications

Application #: 020560 Efficacy Supplement#: 006
Type: SE1 to Original New Drug Application
Approval Date: 25-APR-97
Trade Name: FOSAMAX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX
Efficacy Claim: Prevention of fractures in the treatment of postmenopausal osteoporosis


Application #: 020560 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 25-APR-97
Trade Name: FOSAMAX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX
Efficacy Claim: Prevention of osteoporosis in postmenopausal women


Application #: 050709 Efficacy Supplement#: 006
Type: SE1 to Original New Drug Application
Approval Date: 22-APR-97
Trade Name: PROGRAF
Dosage Form: INJECTABLE
Applicant: FUJISAWA USA INC
Active Ingredient(s): TACROLIMUS
OTC/RX Status: RX
Efficacy Claim: Prophylaxis of organ rejection in patients receiving allogenic kidney transplants


Application #: 050708 Efficacy Supplement#: 008
Type: SE1 to Original New Drug Application
Approval Date: 22-APR-97
Trade Name: PROGRAF
Dosage Form: CAPSULE
Applicant: FUJISAWA USA INC
Active Ingredient(s): TACROLIMUS
OTC/RX Status: RX
Efficacy Claim: Prophylaxis of organ rejection in patients receiving allogenic kidney transplants


Application #: 020406 Efficacy Supplement#: 010
Type: SE1 to Original New Drug Application
Approval Date: 17-APR-97
Trade Name: PREVACID
Dosage Form: CAPSULE, DELAYED RELEASE GRANULES
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Efficacy Claim: Maintenance of healing of duodenal ulcer


Application #: 020375 Efficacy Supplement#: 006
Type: SE3 to Original New Drug Application
Approval Date: 11-APR-97
Trade Name: CLIMARA
Dosage Form: FILM, EXTENDED RELEASE
Applicant: BERLEX
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Efficacy Claim: Use on an alternate application site, the trunk (including the buttocks)


Application #: 017533 Efficacy Supplement#: 023
Type: SE1 to Original New Drug Application
Approval Date: 09-APR-97
Trade Name: KLONOPIN
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX
Efficacy Claim: Treatment of panic disorder (PAD) in a recommended dose range of 1 to 2mg/day (maximum of 4mg)

Approvable Original New Drug Applications


Original Application #: 020652
Approvable Date: 29-APR-97
Trade Name: TESLASCAN
Dosage Form: INJECTABLE
Applicant: NYCOMED INC
Active Ingredient(s): MANGAFODIPIR TRISODIUM
OTC/RX Status: RX


Original Application #: 020626
Approvable Date: 23-APR-97
Trade Name: IMITREX
Dosage Form: SPRAY
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SUMATRIPTAN
OTC/RX Status: RX

Original Application #: 020501
Approvable Date: 22-APR-97
Trade Name: TRANSDERM SCOP
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): SCOPOLAMINE
OTC/RX Status: RX

Original Application #: 020716
Approvable Date: 17-APR-97
Trade Name: VICOPROFEN
Dosage Form: TABLET
Applicant: KNOLL PHARMACEUTICAL CO
Active Ingredient(s): HYDROCODONE BITARTRATE; IBUPROFEN
OTC/RX Status: RX


Original Application #: 020729
Approvable Date: 16-APR-97
Trade Name: UNIRETIC
Dosage Form: TABLET
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications


Original Abbreviated Application # 074638
Approval Date: 30-APR-97
Trade Name: IOPAMIDOL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX


Original Abbreviated Application # 074414
Approval Date: 30-APR-97
Trade Name: MICONAZOLE NITRATE
Dosage Form: SUPPOSITORY
Applicant: G AND W LABORATORIES INC
Active Ingredient(s): MICONAZOLE NITRATE
OTC/RX Status: RX


Original Abbreviated Application # 074357
Approval Date: 30-APR-97
Trade Name: TRAZODONE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: LEMMON COMPANY
Active Ingredient(s): TRAZODONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074738
Approval Date: 28-APR-97
Trade Name: ACYCLOVIR
Dosage Form: SUSPENSION
Applicant: ALPHARMA USPD INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX


Original Abbreviated Application # 074834
Approval Date: 24-APR-97
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: ESI LEDERLE INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

 

Original Abbreviated Application # 074872
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: ESI LEDERLE INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX


Original Abbreviated Application # 074836
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

 

Original Abbreviated Application # 074833
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: AESGEN INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX


Original Abbreviated Application # 074828
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX


Original Abbreviated Application # 074758
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: ABBOTT LABS
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 074750
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: LEK LJUBLJANA PHARMACEUTICAL AND CHEMICAL CO
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074727
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074720
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 074674
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX


Original Abbreviated Application # 074663
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: SANOFI WINTHROP INC
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 074658
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: LEK PHARMACEUTICAL AND CHEMICAL CO DD
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX


Original Abbreviated Application # 074596
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

 

Original Abbreviated Application # 074578
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: NOVOPHARM LTD
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

 

Original Abbreviated Application # 074570
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX


Original Abbreviated Application # 074556
Approval Date: 22-APR-97
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX


Original Abbreviated Application # 089915
Approval Date: 17-APR-97
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: INJECTABLE
Applicant: PHARMACHEMIE BV
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX


Original Abbreviated Application # 089628
Approval Date: 17-APR-97
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: INJECTABLE
Applicant: PHARMACHEMIE BV
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX


Original Abbreviated Application # 074123
Approval Date: 17-APR-97
Trade Name: PINDOLOL
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): PINDOLOL
OTC/RX Status: RX


Original Abbreviated Application # 040177
Approval Date: 17-APR-97
Trade Name: TRIHEXYPHENIDYL HCL
Dosage Form: ELIXIR
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): TRIHEXYPHENIDYL HYDROCHLORIDE
OTC/RX Status: RX


Original Abbreviated Application # 074892
Approval Date: 16-APR-97
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX


Original Abbreviated Application # 040155
Approval Date: 14-APR-97
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): ACETAMINOPHEN; HYDROCODONE BITARTRATE
OTC/RX Status: RX


Original Abbreviated Application # 074903
Approval Date: 11-APR-97
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX


Original Abbreviated Application # 074849
Approval Date: 04-APR-97
Trade Name: CLOMIPRAMINE HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant: NOVOPHARM LTD
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX


Original Abbreviated Application # 074665
Approval Date: 04-APR-97
Trade Name: INDAPAMIDE
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): INDAPAMIDE
OTC/RX Status: RX


Original Abbreviated Application # 074619
Approval Date: 04-APR-97
Trade Name: GLIPIZIDE
Dosage Form: TABLET
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): GLIPIZIDE
OTC/RX Status: RX


Original Abbreviated Application # 074637
Approval Date: 03-APR-97
Trade Name: IOPAMIDOL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES DIAGNOSTICS DIV
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX


Original Abbreviated Application # 074679
Approval Date: 02-APR-97
Trade Name: IOPAMIDOL
Dosage Form: INJECTABLE
Applicant: FUJISAWA USA INC
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX


Original Abbreviated Antibiotic Application # 064146
Approval Date: 02-APR-97
Trade Name: AMIKACIN SULFATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): AMIKACIN SULFATE
OTC/RX Status: RX


Original Abbreviated Application # 074647
Approval Date: 01-APR-97
Trade Name: FLURBIPROFEN
Dosage Form: TABLET
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): FLURBIPROFEN
OTC/RX Status: RX

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


Original Abbreviated Application #: 074713
Tentative Approval Date: 16-APR-97
Trade Name: CISPLATIN
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): CISPLATIN
OTC/RX Status: RX


Original Abbreviated Application #: 074720
Tentative Approval Date: 10-APR-97
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX


Original Abbreviated Application #: 074539
Tentative Approval Date: 03-APR-97
Trade Name: TAMOXIFIEN CITRATE
Dosage Form: TABLET
Applicant: PHARMACHEMIE BV
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications


Application #:020550Labeling Supplement#:004
To Original New Drug Application
Approval Date: 30-APR-97
Trade Name: VALTREX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE
OTC/RX Status: RX

Application #: 015539 Labeling Supplement #: 050 To Original New Drug Application
Approval Date: 30-APR-97
Trade Name: SERAX
Dosage Form: TABLET/CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): OXAZEPAM
OTC/RX Status: RX


Application #: 018631 Labeling Supplement #: 030 To Original New Drug Application
Approval Date: 29-APR-97
Trade Name: TRENTAL
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): PENTOXIFYLLINE
OTC/RX Status: RX


Application #: 018245 Labeling Supplement #: 022 To Original New Drug Application
Approval Date: 29-APR-97
Trade Name: SYNTOCINON
Dosage Form: INJECTABLE
Applicant: SANDOZ PHARMACEUTICALS CORP
Active Ingredient(s): OCYTOCIN
OTC/RX Status: RX


Application #: 020547 Labeling Supplement #: 001 To Original New Drug Application
Approval Date: 28-APR-97
Trade Name: ACCOLATE
Dosage Form: TABLET
Applicant: ZENECA LTD
Active Ingredient(s): ZAFIRLUKAST
OTC/RX Status: RX

Application #: 019758 Labeling Supplement #: 033
To Original New Drug Application
Approval Date: 25-APR-97
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX


Application #: 019758 Labeling Supplement #: 027
To Original New Drug Application
Approval Date: 25-APR-97
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX


Application #: 019758 Labeling Supplement #: 025
To Original New Drug Application
Approval Date: 25-APR-97
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX


Application #: 019758 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 25-APR-97
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX


Application #: 050596 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 24-APR-97
Trade Name: CLAFORAN
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): CEFOTAXIME SODIUM
OTC/RX Status: RX


Application #: 050547 Labeling Supplement #: 045
To Original New Drug Application
Approval Date: 24-APR-97
Trade Name: CLAFORAN
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): CEFOTAXIME SODIUM
OTC/RX Status: RX


Application #: 050517 Labeling Supplement #: 039 To Original New Drug Application
Approval Date: 24-APR-97
Trade Name: MEFOXIN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): CEFOXITIN SODIUM
OTC/RX Status: RX

Application #: 050426 Labeling Supplement#: 019 To Original New Drug Application
Approval Date: 24-APR-97
Trade Name: ILOSONE
Dosage Form: CAPSULE
Applicant: LILLY RESEARCH LABORATORIES
Active Ingredient(s): ERYTHROMYCIN ESTOLATE
OTC/RX Status: RX


Application #: 050365 Labeling Supplement#: 043 To Original New Drug Application
Approval Date: 24-APR-97
Trade Name: ILOSONE
Dosage Form: TABLET
Applicant: LILLY RESEARCH LABORATORIES
Active Ingredient(s): ERYTHROMYCIN ESTOLATE
OTC/RX Status: RX


Application #: 050010 Labeling Supplement#: 022 To Original New Drug Application
Approval Date: 24-APR-97
Trade Name: ILOSONE
Dosage Form: SUSPENSION
Applicant: LILLY RESEARCH LABORATORIES
Active Ingredient(s): ERYTHROMYCIN ESTOLATE
OTC/RX Status: RX

Application #: 019616 Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 24-APR-97
Trade Name: COMPRECIN
Dosage Form: TABLET
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): ENOXACIN
OTC/RX Status: RX

Application #: 050665 Labeling Supplement#: 016 To Original New Drug Application
Approval Date: 23-APR-97
Trade Name: CEFZIL
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFPROZIL
OTC/RX Status: RX

Application #: 020503 Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 22-APR-97
Trade Name: PROVENTIL-HFA
Dosage Form: AEROSOL, METERED
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX


Application #: 050664 Labeling Supplement#: 016 To Original New Drug Application
Approval Date: 21-APR-97
Trade Name: CEFZIL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFPROZIL
OTC/RX Status: RX


Application #: 019684 Labeling Supplement#: 013 To Original New Drug Application
Approval Date: 21-APR-97
Trade Name: PROCARDIA XL
Dosage Form: TABLET
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX


Application #: 018482 Labeling Supplement#: 041 To Original New Drug Application
Approval Date: 21-APR-97
Trade Name: PROCARDIA
Dosage Form: CAPSULE
Applicant: PFIZER INC
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX


Application #: 020051 Labeling Supplement#: 007 To Original New Drug Application
Approval Date: 18-APR-97
Trade Name: GLYNASE
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX


Application #: 019717 Labeling Supplement#: 023 To Original New Drug Application
Approval Date: 18-APR-97
Trade Name: HUMULIN 70/30
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN BIOSYNTHETIC HUMAN; INSULIN SUSP ISOPHANE BIOSYNTHETIC HUMAN
OTC/RX Status: OTC


Application #: 012122 Labeling Supplement#: 040 To Original New Drug Application
Approval Date: 18-APR-97
Trade Name: GLUCAGON
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): GLUCAGON HYDROCHLORIDE
OTC/RX Status: RX


Application #: 019991 Labeling Supplement#: 021 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: NOVOLIN 70/30
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN BIOSYNTHETIC HUMAN; INSULIN SUSP ISOPHANE BIOSYNTHETIC HUMAN
OTC/RX Status: OTC


Application #: 019965 Labeling Supplement#: 017 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: NOVOLIN L
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN ZINC SUSP BIOSYNTHETIC HUMAN
OTC/RX Status: OTC


Application #: 019959 Labeling Supplement#: 021 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: NOVOLIN N
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN SUSP ISOPHANE BIOSYNTHETIC HUMAN
OTC/RX Status: OTC


Application #: 019938 Labeling Supplement#: 020 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: NOVOLIN R
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN BIOSYNTHETIC HUMAN
OTC/RX Status: OTC


Application #: 019450 Labeling Supplement#: 017 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: VELOSULIN HUMAN
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN SEMISYNTHETIC PURIFIED HUMAN
OTC/RX Status: OTC


Application #: 018781 Labeling Supplement#: 047 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: HUMULIN N
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN SUSP ISOPHANE BIOSYNTHETIC HUMAN
OTC/RX Status: OTC


Application #: 018780 Labeling Supplement#: 055 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: HUMULIN R
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN BIOSYNTHETIC HUMAN
OTC/RX Status: OTC


Application #: 018623 Labeling Supplement#: 027 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: NPH PURIFIED PORK ISOPHANE INSULIN
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN SUSP ISOPHANE PURIFIED PORK
OTC/RX Status: OTC


Application #: 018383 Labeling Supplement#: 025 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: LENTE
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN ZINC SUSP PURIFIED PORK
OTC/RX Status: OTC


Application #: 018381 Labeling Supplement#: 027 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: REGULAR PURIFIED PORK INSULIN
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN PURIFIED PORK
OTC/RX Status: OTC


Application #: 015230 Labeling Supplement#: 023 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: AMICAR
Dosage Form: SYRUP
Applicant: IMMUNEX CORP
Active Ingredient(s): AMINOCAPROIC ACID
OTC/RX Status: RX


Application #: 015229 Labeling Supplement#: 028 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: AMICAR
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): AMINOCAPROIC ACID
OTC/RX Status: RX


Application #: 015197 Labeling Supplement#: 030 To Original New Drug Application
Approval Date: 16-APR-97
Trade Name: AMICAR
Dosage Form: TABLET
Applicant: IMMUNEX CORP
Active Ingredient(s): AMINOCAPROIC ACID
OTC/RX Status: RX


Application #: 020605 Labeling Supplement#: 001 To Original New Drug Application
Approval Date: 15-APR-97
Trade Name: ZOFRAN
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX


Application #: 020103 Labeling Supplement#: 013 To Original New Drug Application
Approval Date: 15-APR-97
Trade Name: ZOFRAN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX


Application #: 019898 Labeling Supplement#: 017 To Original New Drug Application
Approval Date: 15-APR-97
Trade Name: PRAVACHOL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): PRAVASTATIN SODIUM
OTC/RX Status: RX


Application #: 019810 Labeling Supplement#: 048 To Original New Drug Application
Approval Date: 15-APR-97
Trade Name: PRILOSEC
Dosage Form: CAPSULE, DELAYED RELEASE PELLETS
Applicant: ASTRA MERCK INC
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX


Application #: 050611 Labeling Supplement#: 016 To Original New Drug Application
Approval Date: 14-APR-97
Trade Name: PCE
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): ERYTHROMYCIN
OTC/RX Status: RX


Application #: 050297 Labeling Supplement#: 017 To Original New Drug Application
Approval Date: 14-APR-97
Trade Name: ERYPED
Dosage Form: TABLET, CHEWABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): ERYTHROMYCIN ETHYLSUCCINATE
OTC/RX Status: RX


Application #: 050207 Labeling Supplement#: 051 To Original New Drug Application
Approval Date: 14-APR-97
Trade Name: E.E.S.
Dosage Form: GRANULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): ERYTHROMYCIN ETHYLSUCCINATE
OTC/RX Status: RX

Application #: 020564 Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 11-APR-97
Trade Name: EPIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX


Application #: 020596 Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 11-APR-97
Trade Name: EPIVIR
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX


Application #: 019959 Labeling Supplement#: 019 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: NOVOLIN N
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN SUSP ISOPHANE BIOSYNTHETIC HUMAN
OTC/RX Status: OTC


Application #: 019991 Labeling Supplement#: 019 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: NOVOLIN 70/30
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN BIOSYNTHETIC HUMAN; INSULIN SUSPENION ISOPHANE BIOSYNTHETIC HUMAN
OTC/RX Status: OTC


Application #: 019965 Labeling Supplement#: 016 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: NOVOLIN L
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN ZINC SUSP BIOSYNTHETIC HUMAN
OTC/RX Status: OTC


Application #: 019938 Labeling Supplement#: 019 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: NOVOLIN R
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN BIOSYNTHETIC HUMAN
OTC/RX Status: OTC


Application #: 019450 Labeling Supplement#: 016 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: VELOSULIN HUMAN
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN SEMISYNTHETIC PURIFIED HUMAN
OTC/RX Status: OTC


Application #: 018623 Labeling Supplement#: 025 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: NPH PURIFIED PORK ISOPHANE INSULIN
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN SUSP ISOPHANE PURIFIED PORK
OTC/RX Status: OTC


Application #: 018383 Labeling Supplement#: 024 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: LENTE
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN ZINC SUSP PURIFIED PORK
OTC/RX Status: OTC


Application #: 018381 Labeling Supplement#: 025 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: REGULAR PURIFIED PORK INSULIN
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): INSULIN PURIFIED PORK
OTC/RX Status: OTC


Application #: 017543 Labeling Supplement#: 030 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: LUDIOMIL
Dosage Form: TABLET
Applicant: CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP
Active Ingredient(s): MAPROTILINE HYDROCHLORIDE
OTC/RX Status: RX


Application #: 017543 Labeling Supplement#: 029 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: LUDIOMIL
Dosage Form: TABLET
Applicant: CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP
Active Ingredient(s): MAPROTILINE HYDROCHLORIDE
OTC/RX Status: RX


Application #: 017543 Labeling Supplement#: 026 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: LUDIOMIL
Dosage Form: TABLET
Applicant: CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP
Active Ingredient(s): MAPROTILINE HYDROCHLORIDE
OTC/RX Status: RX


Application #: 017543 Labeling Supplement#: 021 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: LUDIOMIL
Dosage Form: TABLET
Applicant: CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP
Active Ingredient(s): MAPROTILINE HYDROCHLORIDE
OTC/RX Status: RX


Application #: 017543 Labeling Supplement#: 019 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: LUDIOMIL
Dosage Form: TABLET
Applicant: CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP
Active Ingredient(s): MAPROTILINE HYDROCHLORIDE
OTC/RX Status: RX


Application #: 017543 Labeling Supplement#: 018 To Original New Drug Application
Approval Date: 10-APR-97
Trade Name: LUDIOMIL
Dosage Form: TABLET
Applicant: CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP
Active Ingredient(s): MAPROTILINE HYDROCHLORIDE
OTC/RX Status: RX


Application #:020033 Labeling Supplement#: 012 To Original New Drug Application
Approval Date: 09-APR-97
Trade Name: LOTENSIN HCT
Dosage Form: TABLET
Applicant: CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP
Active Ingredient(s): BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX


Application #: 020719 Labeling Supplement#: 004 To Original New Drug Application
Approval Date: 08-APR-97
Trade Name: PRELAY
Dosage Form: TABLET
Applicant: SANKYO USA CORP
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX


Application #: 020719 Labeling Supplement#: 001 To Original New Drug Application
Approval Date: 08-APR-97
Trade Name: PRELAY
Dosage Form: TABLET
Applicant: SANKYO USA CORP
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX


Application #: 016618 Labeling Supplement#: 038 To Original New Drug Application
Approval Date: 08-APR-97
Trade Name: PONDIMIN
Dosage Form: TABLET
Applicant: AH ROBINS CO
Active Ingredient(s): FENFLURAMINE HYDROCHLORIDE
OTC/RX Status: RX

 

Application #: 015539 Labeling Supplement#:047 To Original New Drug Application
Permitted Date: 08-APR-97
Trade Name: SERAX
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): OXAZEPAM
OTC/RX Status: RX


Application #: 015539 Labeling Supplement#:042 To Original New Drug Application
Permitted Date: 08-APR-97
Trade Name: SERAX
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): OXAZEPAM
OTC/RX Status: RX


Application #: 015539 Labeling Supplement#:041 To Original New Drug Application
Permitted Date: 08-APR-97
Trade Name: SERAX
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): OXAZEPAM
OTC/RX Status: RX

Application #: 020720 Labeling Supplement#: 004 To Original New Drug Application
Approval Date: 04-APR-97
Trade Name: REZULIN
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX


Application #: 020720 Labeling Supplement#: 001 To Original New Drug Application
Approval Date: 04-APR-97
Trade Name: REZULIN
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX


Application #: 017441 Labeling Supplement#: 151 To Original New Drug Application
Approval Date: 04-APR-97
Trade Name: INFED
Dosage Form: INJECTABLE
Applicant: SCHEIN PHARMACEUTICAL INC
Active Ingredient(s): IRON DEXTRAN
OTC/RX Status: RX


Application #: 017441 Labeling Supplement#: 150 To Original New Drug Application
Approval Date: 04-APR-97
Trade Name: INFED
Dosage Form: INJECTABLE
Applicant: SCHEIN PHARMACEUTICAL INC
Active Ingredient(s): IRON DEXTRAN
OTC/RX Status: RX


Application #: 020403 Labeling Supplement#: 004 To Original New Drug Application
Approval Date: 02-APR-97
Trade Name: ZOFRAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX


Application #: 020007 Labeling Supplement#: 023 To Original New Drug Application
Approval Date: 02-APR-97
Trade Name: ZOFRAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX


Application #: 019906 Labeling Supplement#: 019 To Original New Drug Application
Approval Date: 02-APR-97
Trade Name: ANAFRANIL
Dosage Form: CAPSULE
Applicant: CIBA GEIGY CORP PHARMACEUTICALS DIV
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX


Application #: 019906 Labeling Supplement#: 017 To Original New Drug Application
Approval Date: 02-APR-97
Trade Name: ANAFRANIL
Dosage Form: CAPSULE
Applicant: CIBA GEIGY CORP PHARMACEUTICALS DIV
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX


Application#: 017498 LabelingSupplement: 019 To Original New Drug Application
Approval Date: 02-APR-97
Trade Name: MICRONASE
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX


Application #: 017498 Labeling Supplement#: 018 To Original New Drug Application
Approval Date: 02-APR-97
Trade Name: MICRONASE
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX


Application #: 016267 Labeling Supplement#: 028 To Original New Drug Application
Approval Date: 02-APR-97
Trade Name: DESFERAL
Dosage Form: INJECTABLE
Applicant: CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP
Active Ingredient(s): DEFEROXAMINE MESYLATE
OTC/RX Status: RX

 

 

 

 

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