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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
May 1956

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 September 24, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
05/01/1956 MYTELASE
NDA #010155		 ORIG-1 AMBENONIUM CHLORIDE SANOFI AVENTIS US Type 1 - New Molecular Entity Approval
05/08/1956 CYTOMEL
NDA #010379		 ORIG-1 LIOTHYRONINE SODIUM KING PHARMS Type 1 - New Molecular Entity Approval
05/25/1956 ISUPREL
NDA #010515		 ORIG-1 ISOPROTERENOL HYDROCHLORIDE BAUSCH Type 3 - New Dosage Form Approval
05/31/1956 ATARAX
NDA #010485		 ORIG-1 HYDROXYZINE HYDROCHLORIDE ROERIG Type 3 - New Dosage Form Approval
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