Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
August 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 June 01, 2020.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
08/01/1988 DIPROLENE
NDA #019716
BETAMETHASONE DIPROPIONATE Type 3 - New Dosage Form Standard MERCK SHARP DOHME
08/02/1988 PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
NDA #019428
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard CENT PHARMS
08/11/1988 THIOLA
NDA #019569
TIOPRONIN Type 1 - New Molecular Entity Priority MISSION PHARMA
08/17/1988 ROGAINE (FOR MEN)
NDA #019501
MINOXIDIL Type 3 - New Dosage Form Priority JOHNSON AND JOHNSON
08/17/1988 ROGAINE (FOR WOMEN)
NDA #019501
MINOXIDIL Type 3 - New Dosage Form Priority JOHNSON AND JOHNSON
08/18/1988 TOBRADEX
NDA #050592
DEXAMETHASONE; TOBRAMYCIN Type 4 - New Combination Standard NOVARTIS
08/26/1988 VASOCIDIN
NDA #018988
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM Type 4 - New Combination Standard NOVARTIS
08/26/1988 MICRO-K LS
NDA #019561
POTASSIUM CHLORIDE Type 3 - New Dosage Form Standard KV PHARM

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