Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
September 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 December 14, 2019.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
09/02/1988 DILATRATE-SR
NDA #019790
ISOSORBIDE DINITRATE Type 5 - New Formulation or New Manufacturer Standard AUXILIUM PHARMS LLC
09/16/1988 RETIN-A
NDA #019049
TRETINOIN Type 3 - New Dosage Form Standard VALEANT BERMUDA
09/23/1988 TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #019520
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
09/23/1988 TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER
NDA #019520
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
09/23/1988 TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #019520
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
09/23/1988 TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #019520
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
09/23/1988 TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019520
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
09/23/1988 TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #019520
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
09/23/1988 TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER
NDA #019520
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
09/23/1988 TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #019520
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
09/23/1988 TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #019520
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
09/23/1988 TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019520
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
09/28/1988 TOBRADEX
NDA #050616
DEXAMETHASONE; TOBRAMYCIN Type 3 - New Dosage Form Standard NOVARTIS

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