Drug Approvals for January 1999

Definitions and Notes

January 1999

Original New Drug Applications

Original Application #: 020781
Approval Date: 27-JAN-99
Trade Name: ZOFRAN ODT
Chemical Type:
Therapeutic Potential:
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON
OTC/RX Status: RX
Indication(s): For the prevention of chemotherapy and radiation-induced nausea and vomiting, and prevention of postoperative nausea and vomiting

Original Application #: 020863
Approval Date: 15-JAN-99
Trade Name: PLETAL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: OTSUKA AMERICA PHARMACEUTICAL INC
Active Ingredient(s): CILOSTAZOL
OTC/RX Status: RX
Indication(s): For the reductions of symptoms of intermittent claudication

Efficacy Supplemental New Drug Applications

Application #: 050757 Efficacy Supplement #: 002
Type: SE2 to Original New Drug Application
Approval Date: 22-JAN-99
Trade Name: PREVPAC
Dosage Form: TABLET
Applicant: TAP HOLDINGS INC
Active Ingredient(s): AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
OTC/RX Status: RX
Efficacy Claim:For the eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence

Application #: 020538 Efficacy Supplement#: 006
Type: to Original New Drug Application
Approval Date: 08-JAN-99
Trade Name: ESTRADIOL
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: MENOREST MANUFACTURING INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Efficacy Claim: For a new formulation with various strengths based on surface area difference

Application #: 020076 Efficacy Supplement#: 013
Type: SE4 to Original New Drug Application
Approval Date: 07-JAN-99
Trade Name: HABITROL
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: NOVARTIS CONSUMER HEALTH INC
Active Ingredient(s): NICOTINE
OTC/RX Status: RX
Efficacy Claim: For the relief of nicotine withdrawal symptoms

Application #: 020500 Efficacy Supplement#: 005
Type: SE1 to Original New Drug Application
Approval Date: 05-JAN-99
Trade Name: MEPRON
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ATOVAQUONE
OTC/RX Status: RX
Efficacy Claim: For the prevention of Pneumocystis carinii pneumonia (PCP)

Approvable Original New Drug Applications

Original Application #: 020973
Approvable Date: 29-JAN-99
Trade Name: ACIPHEX
Dosage Form: TABLET
Applicant: EISAI INCORPORATED
Active Ingredient(s): RABEPRAZOLE SODIUM
OTC/RX Status: RX

Original Application #: 020859
Approvable Date: 06-JAN-99
Trade Name: SONATA
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ZALEPLON
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075039
Approval Date: 29-JAN-99
Trade Name: OXYBUTYNIN
Dosage Form: SYRUP
Applicant: MIKART INC
Active Ingredient(s): OXYBUTYNIN
OTC/RX Status: RX

Original Abbreviated Application # 075030
Approval Date: 29-JAN-99
Trade Name: PEMOLINE
Dosage Form: TABLET
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): PEMOLINE
OTC/RX Status: RX

Original Abbreviated Application # 074993
Approval Date: 29-JAN-99
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Original Abbreviated Application # 040249
Approval Date: 29-JAN-99
Trade Name: ORPHENADRINE CITRATE
Dosage Form: TABLET
Applicant: KIEL LABORATORIES INC
Active Ingredient(s): ORPHENADRINE CITRATE
OTC/RX Status: RX

Original Abbreviated Application # 075180
Approval Date: 28-JAN-99
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): RANITIDINE
OTC/RX Status: RX

Original Abbreviated Application # 075260
Approval Date: 25-JAN-99
Trade Name: TRETINOIN
Dosage Form: SOLUTION
Applicant: MORTON GROVE PHARMACEUTICALS, INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Original Abbreviated Application # 075090
Approval Date: 26-JAN-99
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: STASON INDUSTRIAL CORP
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 040224
Approval Date: 26-JAN-99
Trade Name: CHLORPROMAZINE HYDROCHLORIDE
Dosage Form: CONCENTRATE
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): CHLORPROMAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074830
Approval Date: 25-JAN-99
Trade Name: DESMOPRESSIN ACETATE
Dosage Form: SOLUTION
Applicant: BAUSCH AND LOMB PHARMACEUTICALS INC
Active Ingredient(s): DESMOPRESSIN ACETATE
OTC/RX Status: RX

Original Abbreviated Application # 075102
Approval Date: 04-JAN-99
Trade Name: PROPOFOL INJECTABLE
Dosage Form: EMULSION, INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): PROPOFOL
OTC/RX Status: RX

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

Original Abbreviated Application #: 075370
Tentative Approval Date: 29-JAN-99
Trade Name: ENALAPRIL MALEATE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Application #: 075294
Tentative Approval Date: 29-JAN-99
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: REDDY-CHEMINOR INC
Active Ingredient(s): RANITIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075296
Tentative Approval Date: 28-JAN-99
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS INC
Active Ingredient(s): RANITIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075161
Tentative Approval Date: 28-JAN-99
Trade Name: TICLOPIDINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICALS INC
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075094
Tentative Approval Date: 26-JAN-99
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020808 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 28-JAN-99
Trade Name: VISIPAQUE 270
Dosage Form: INJECTABLE
Applicant: NYCOMED INC
Active Ingredient(s): IODIXANOL
OTC/RX Status: RX

Application #: 050679 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 27-JAN-99
Trade Name: MAXIPIME
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFEPIME HYDROCHLORIDE (ARGININE FORMULATION)
OTC/RX Status: RX

Application #: 020358 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 26-JAN-99
Trade Name: WELLBUTRIN
Dosage Form: TABLET, SUSTAINED ACTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016776 Labeling Supplement #: 036
To Original New Drug Application
Approval Date: 26-JAN-99
Trade Name: SORBITRATE CHEWABLE TAB
Dosage Form: TABLET, CHEWABLE
Applicant: ZENECA INC
Active Ingredient(s): ISOSORBIDE DINITRATE
OTC/RX Status: RX

Application #: 016192 Labeling Supplement #: 043
To Original New Drug Application
Approval Date: 26-JAN-99
Trade Name: SORBITRATE
Dosage Form: TABLET
Applicant: ZENECA INC
Active Ingredient(s): ISOSORBIDE DINITRATE
OTC/RX Status: RX

Application #: 020624 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 25-JAN-99
Trade Name: ANZEMET
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DOLASETRON MESYLATE MONOHYDRATE
OTC/RX Status: RX

Application #: 020623 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 25-JAN-99
Trade Name: ANZEMET
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DOLASETRON MESYLATE MONOHYDRATE
OTC/RX Status: RX

Application #: 019777 Labeling Supplement#: 035
To Original New Drug Application
Approval Date: 20-JAN-99
Trade Name: ZESTRIL
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Application #: 020406 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 14-JAN-99
Trade Name: PREVACID
Dosage Form: CAPSULE, DELAYED RELEASE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX

Application #: 020215 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 13-JAN-99
Trade Name: MONOKET
Dosage Form: TABLET
Applicant: SCHWARZ GMBH
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX

Application #: 019790 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 13-JAN-99
Trade Name: DILATRATE-SR
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): ISOSORBIDE DINITRATE
OTC/RX Status: RX

Application #: 018705 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 13-JAN-99
Trade Name: NITROLINGUAL
Dosage Form: AEROSOL
Applicant: G POHL BOSKAMP GMBH AND CO
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Application #: 020592 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 11-JAN-99
Trade Name: ZYPREXA
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): OLANZAPINE
OTC/RX Status: RX

Application #: 020262 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 08-JAN-99
Trade Name: TAXOL
Dosage Form: INJECTABLE
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX

Application #: 020262 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 08-JAN-99
Trade Name: TAXOL
Dosage Form: INJECTABLE
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX

Application #: 020262 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 08-JAN-99
Trade Name: TAXOL
Dosage Form: INJECTABLE
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX

Application #: 020262 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 08-JAN-99
Trade Name: TAXOL
Dosage Form: INJECTABLE
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX

Application #: 017876 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 08-JAN-99
Trade Name: LOESTRIN 21 1/20
Dosage Form: TABLET
Applicant: PARKE DAVIS
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017875 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 08-JAN-99
Trade Name: LOESTRIN 21 1.5/30
Dosage Form: TABLET
Applicant: PARKE DAVIS
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017355 Labeling Supplement#: 043
To Original New Drug Application
Approval Date: 08-JAN-99
Trade Name: LOESTRIN FE 1.5/30
Dosage Form: TABLET
Applicant: PARKE DAVIS
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL;
OTC/RX Status: RX

Application #: 017354 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 08-JAN-99
Trade Name: LOESTRIN FE 1/20
Dosage Form: TABLET
Applicant: PARKE DAVIS
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017919 Labeling Supplement#: 066
To Original New Drug Application
Approval Date: 06-JAN-99
Trade Name: ORTHO-NOVUM 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017735 Labeling Supplement#: 084
To Original New Drug Application
Approval Date: 06-JAN-99
Trade Name: MODICON 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 020539 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 05-JAN-99
Trade Name: LAMISIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORPORATION
Active Ingredient(s): TERBINAFINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018972 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 05-JAN-99
Trade Name: CORDARONE
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018972 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 05-JAN-99
Trade Name: CORDARONE
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020869 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 04-JAN-99
Trade Name: COSOPT
Dosage Form: SOLUTION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 020740 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 04-JAN-99
Trade Name: BAYCOL
Dosage Form: TABLET
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): CERIVASTATIN SODIUM
OTC/RX Status: RX

Application #: 020261 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 04-JAN-99
Trade Name: LESCOL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): FLUVASTATIN SODIUM
OTC/RX Status: RX

Application #: 019906 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 04-JAN-99
Trade Name: ANAFRANIL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX