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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
September 1955

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 May 06, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
09/02/1955 TETRACYN
ANDA #060095		 ORIG-1 TETRACYCLINE HYDROCHLORIDE PFIPHARMECS Approval
09/09/1955 BIPHETAMINE 12.5
NDA #010093		 ORIG-1 AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX UCB INC Type 2 - New Active Ingredient Approval
09/09/1955 BIPHETAMINE 20
NDA #010093		 ORIG-1 AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX UCB INC Type 2 - New Active Ingredient Approval
09/09/1955 BIPHETAMINE 7.5
NDA #010093		 ORIG-1 AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX UCB INC Type 2 - New Active Ingredient Approval
09/30/1955 MEPHYTON
NDA #010104		 ORIG-1 PHYTONADIONE BAUSCH Type 3 - New Dosage Form Approval
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