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 August 13, 2020.

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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