Drugs@FDA: FDA Approved Drug Products

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Original New Drug Application
NDA and BLA) Approvals
September 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 August 17, 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 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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