Drugs@FDA: FDA Approved Drug Products

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Original New Drug Application
NDA and BLA) Approvals
December 1990

This report lists all applications approved for the first time during the selected month. It includes New Molecular Entities (NMEs) and new biologics. * It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history.* Not all biologics are in Drugs@FDA.

This report was produced on June 17, 2019.

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 ALLERGAN SALES LLC
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 PHARMS CORP
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination
Meaning
Priority: Review designation assigned to applications for drugs that treat serious conditions and provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies
Standard: Review designation assigned to applications for drugs that do not meet the priority review designation criteria

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