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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
January 1989

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 May 02, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
01/23/1989 CARDIZEM SR
NDA #019471		 DILTIAZEM HYDROCHLORIDE Type 3 - New Dosage Form Standard BIOVAIL
01/25/1989 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019805		 HEPARIN SODIUM Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
01/25/1989 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019805		 HEPARIN SODIUM Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
01/26/1989 LUPRON DEPOT
NDA #019732		 LEUPROLIDE ACETATE Type 3 - New Dosage Form Priority ABBVIE ENDOCRINE INC
01/27/1989 EULEXIN
NDA #018554		 FLUTAMIDE Type 1 - New Molecular Entity Priority SCHERING
01/31/1989 CEFPIRAMIDE SODIUM
NDA #050633		 CEFPIRAMIDE SODIUM Type 1 - New Molecular Entity Standard WYETH AYERST
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