Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
October 1986

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 January 17, 2022.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
10/15/1986 DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%
NDA #019099
DOPAMINE HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard B BRAUN
10/15/1986 DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019099
DOPAMINE HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard B BRAUN
10/15/1986 PEPCID
NDA #019462
FAMOTIDINE Type 1 - New Molecular Entity Standard BAUSCH
10/16/1986 HUMATROPE
BLA #019640
SOMATROPIN LILLY
10/17/1986 AMINOSYN-PF 10%
NDA #019492
AMINO ACIDS Type 3 - New Dosage Form Standard ICU MEDICAL INC
10/22/1986 CYSTEINE HYDROCHLORIDE
NDA #019523
CYSTEINE HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
10/27/1986 TENEX
NDA #019032
GUANFACINE HYDROCHLORIDE Type 1 - New Molecular Entity Standard PROMIUS PHARMA
10/30/1986 OXSORALEN-ULTRA
NDA #019600
METHOXSALEN Type 3 - New Dosage Form Standard BAUSCH
10/31/1986 CIBACALCIN
NDA #018470
CALCITONIN HUMAN Type 1 - New Molecular Entity Priority NOVARTIS
10/31/1986 TECHNESCAN HIDA
NDA #018489
TECHNETIUM TC-99M LIDOFENIN KIT Type 1 - New Molecular Entity Standard DRAXIMAGE
10/31/1986 PROVOCHOLINE
NDA #019193
METHACHOLINE CHLORIDE Type 1 - New Molecular Entity Priority METHAPHARM
10/31/1986 VASERETIC
NDA #019221
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE Type 4 - New Combination Standard BAUSCH
10/31/1986 NOROXIN
NDA #019384
NORFLOXACIN Type 1 - New Molecular Entity Priority MERCK

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