Drugs@FDA: FDA Approved Drug Products

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Original New Drug Application
NDA and BLA) Approvals
August 1988

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 September 15, 2019.

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 PHARMS CORP
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
* 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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