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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
January 1990

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 November 30, 2022.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
01/29/1990 DIFLUCAN
NDA #019949
FLUCONAZOLE Type 1 - New Molecular Entity Priority PFIZER
01/29/1990 DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950
FLUCONAZOLE Type 3 - New Dosage Form Standard PFIZER
01/29/1990 DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950
FLUCONAZOLE Type 3 - New Dosage Form Standard PFIZER
01/29/1990 DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950
FLUCONAZOLE Type 3 - New Dosage Form Standard PFIZER
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