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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
December 1988

This report includes NDAs [including NDAs for new molecular entities (NMEs)] and BLAs (including new biological products) approved for the first time during the selected month. Original BLA/NDA approvals by CBER are not included in Drugs@FDA. This report does not include approved NDA or BLA supplements, approved ANDAs, or tentatively approved ANDAs/NDAs.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on April 19, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
12/02/1988 PHARMASEAL SCRUB CARE
NDA #019793		 CHLORHEXIDINE GLUCONATE Type 5 - New Formulation or New Manufacturer Standard CAREFUSION 2200
12/05/1988 QUESTRAN LIGHT
NDA #019669		 CHOLESTYRAMINE Type 3 - New Dosage Form Standard BRISTOL MYERS
12/20/1988 THALITONE
NDA #019574		 CHLORTHALIDONE Type 3 - New Dosage Form Standard CASPER PHARMA LLC
12/21/1988 CARDENE
NDA #019488		 NICARDIPINE HYDROCHLORIDE Type 1 - New Molecular Entity Standard CHIESI
12/22/1988 ETHAMOLIN
NDA #019357		 ETHANOLAMINE OLEATE Type 1 - New Molecular Entity Priority QOL MEDCL
12/23/1988 PROFENAL
NDA #019387		 SUPROFEN Type 3 - New Dosage Form Standard ALCON
12/27/1988 CYTOTEC
NDA #019268		 MISOPROSTOL Type 1 - New Molecular Entity Priority PFIZER
12/28/1988 NIMOTOP
NDA #018869		 NIMODIPINE Type 1 - New Molecular Entity Priority BAYER PHARMS
12/28/1988 CARTROL
NDA #019204		 CARTEOLOL HYDROCHLORIDE Type 1 - New Molecular Entity Standard ABBVIE
12/30/1988 PERMAX
NDA #019385		 PERGOLIDE MESYLATE Type 1 - New Molecular Entity Priority VALEANT PHARM INTL
12/30/1988 ZANTAC
NDA #019675		 RANITIDINE HYDROCHLORIDE Type 3 - New Dosage Form Standard GLAXO GRP LTD
12/30/1988 OPTIRAY 160
NDA #019710		 IOVERSOL Type 1 - New Molecular Entity Standard LIEBEL-FLARSHEIM
12/30/1988 OPTIRAY 240
NDA #019710		 IOVERSOL Type 1 - New Molecular Entity Standard LIEBEL-FLARSHEIM
12/30/1988 OPTIRAY 300
NDA #019710		 IOVERSOL Type 1 - New Molecular Entity Standard LIEBEL-FLARSHEIM
12/30/1988 OPTIRAY 320
NDA #019710		 IOVERSOL Type 1 - New Molecular Entity Standard LIEBEL-FLARSHEIM
12/30/1988 OPTIRAY 350
NDA #019710		 IOVERSOL Type 1 - New Molecular Entity Standard LIEBEL-FLARSHEIM
12/30/1988 LOPROX
NDA #019824		 CICLOPIROX Type 3 - New Dosage Form Standard MEDIMETRIKS PHARMS
12/30/1988 OXISTAT
NDA #019828		 OXICONAZOLE NITRATE Type 1 - New Molecular Entity Standard FOUGERA PHARMS
12/30/1988 CERETEC
NDA #019829		 TECHNETIUM TC-99M EXAMETAZIME KIT Type 1 - New Molecular Entity Priority GE HEALTHCARE
12/30/1988 MESNEX
NDA #019884		 MESNA Type 1 - New Molecular Entity Priority BAXTER HLTHCARE
12/30/1988 CERADON
NDA #050601		 CEFOTIAM HYDROCHLORIDE Type 1 - New Molecular Entity Standard TAKEDA
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