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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
December 1959

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

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 April 25, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
12/07/1959 NATURETIN-10
NDA #012164		 ORIG-1 BENDROFLUMETHIAZIDE APOTHECON Type 3 - New Dosage Form Approval
12/07/1959 NATURETIN-2.5
NDA #012164		 ORIG-1 BENDROFLUMETHIAZIDE APOTHECON Type 3 - New Dosage Form Approval
12/07/1959 NATURETIN-5
NDA #012164		 ORIG-1 BENDROFLUMETHIAZIDE APOTHECON Type 3 - New Dosage Form Approval
12/14/1959 ORETICYL 25
NDA #012148		 ORIG-1 DESERPIDINE; HYDROCHLOROTHIAZIDE ABBVIE Type 4 - New Combination Approval
12/14/1959 ORETICYL 50
NDA #012148		 ORIG-1 DESERPIDINE; HYDROCHLOROTHIAZIDE ABBVIE Type 4 - New Combination Approval
12/14/1959 ORETICYL FORTE
NDA #012148		 ORIG-1 DESERPIDINE; HYDROCHLOROTHIAZIDE ABBVIE Type 4 - New Combination Approval
12/21/1959 COGENTIN
NDA #012015		 ORIG-1 BENZTROPINE MESYLATE EPIC PHARMA LLC Type 3 - New Dosage Form Approval
12/23/1959 PROLIXIN
NDA #012145		 ORIG-1 FLUPHENAZINE HYDROCHLORIDE APOTHECON Type 3 - New Dosage Form Approval
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