Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
December 1990

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 February 19, 2020.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
12/05/1990 DIAZEPAM
NDA #020124
DIAZEPAM Type 3 - New Dosage Form Standard US ARMY
12/10/1990 NORPLANT
NDA #019897
LEVONORGESTREL Type 3 - New Dosage Form Priority POPULATION COUNCIL
12/10/1990 PHOSLO
NDA #019976
CALCIUM ACETATE Type 3 - New Dosage Form Priority FRESENIUS MEDCL
12/10/1990 NORPLANT SYSTEM IN PLASTIC CONTAINER
NDA #020088
LEVONORGESTREL Type 3 - New Dosage Form Priority WYETH PHARMS INC
12/13/1990 CONDYLOX
NDA #019795
PODOFILOX Type 3 - New Dosage Form Priority TEVA BRANDED PHARM
12/13/1990 IV PERSANTINE
NDA #019817
DIPYRIDAMOLE Type 3 - New Dosage Form Priority BOEHRINGER INGELHEIM
12/14/1990 CUTIVATE
NDA #019957
FLUTICASONE PROPIONATE Type 1 - New Molecular Entity Standard FOUGERA PHARMS
12/14/1990 PRIMAXIN
NDA #050630
CILASTATIN SODIUM; IMIPENEM Type 3 - New Dosage Form Standard MERCK
12/17/1990 ULTRAVATE
NDA #019968
HALOBETASOL PROPIONATE Type 1 - New Molecular Entity Standard SUN PHARM INDS INC
12/18/1990 ROWASA
NDA #019919
MESALAMINE Type 3 - New Dosage Form Standard MEDA PHARMS
12/18/1990 CUTIVATE
NDA #019958
FLUTICASONE PROPIONATE Type 3 - New Dosage Form Standard FOUGERA PHARMS
12/19/1990 CARDIOTEC
NDA #019928
TECHNETIUM TC-99M TEBOROXIME KIT Type 1 - New Molecular Entity Priority BRACCO
12/20/1990 DYNACIRC
NDA #019546
ISRADIPINE Type 1 - New Molecular Entity Standard SMITHKLINE BEECHAM
12/21/1990 CARDIOLITE
NDA #019785
TECHNETIUM TC-99M SESTAMIBI KIT Type 1 - New Molecular Entity Standard LANTHEUS MEDCL
12/21/1990 MIRALUMA
NDA #019785
TECHNETIUM TC-99M SESTAMIBI KIT Type 1 - New Molecular Entity Standard LANTHEUS MEDCL
12/26/1990 PROSOM
NDA #019080
ESTAZOLAM Type 1 - New Molecular Entity Standard ABBOTT
12/26/1990 CONCENTRAID
NDA #019776
DESMOPRESSIN ACETATE Type 5 - New Formulation or New Manufacturer Standard FERRING
12/26/1990 CIPRO
NDA #019847
CIPROFLOXACIN Type 3 - New Dosage Form Standard BAYER HLTHCARE
12/26/1990 CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019857
CIPROFLOXACIN Type 3 - New Dosage Form Standard BAYER HLTHCARE
12/26/1990 CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019858
CIPROFLOXACIN Type 3 - New Dosage Form Standard BAYER PHARMS
12/26/1990 HEXALEN
NDA #019926
ALTRETAMINE Type 1 - New Molecular Entity Priority EISAI INC
12/27/1990 ULTRAVATE
NDA #019967
HALOBETASOL PROPIONATE Type 3 - New Dosage Form Standard SUN PHARM INDS INC
12/28/1990 BEPADIN
NDA #019001
BEPRIDIL HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard MEDPOINTE PHARM HLC
12/28/1990 VASCOR
NDA #019002
BEPRIDIL HYDROCHLORIDE Type 1 - New Molecular Entity Priority JOHNSON AND JOHNSON
12/28/1990 FLOXIN
NDA #019735
OFLOXACIN Type 1 - New Molecular Entity Standard JANSSEN PHARMS
12/28/1990 GEREF
NDA #019863
SERMORELIN ACETATE Type 1 - New Molecular Entity Standard EMD SERONO
12/31/1990 DAPIPRAZOLE HYDROCHLORIDE
NDA #019849
DAPIPRAZOLE HYDROCHLORIDE Type 1 - New Molecular Entity Priority FERA PHARMS
12/31/1990 CILOXAN
NDA #019992
CIPROFLOXACIN HYDROCHLORIDE Type 3 - New Dosage Form Standard NOVARTIS

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