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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
August 1947

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 19, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
08/13/1947 DOLOPHINE HYDROCHLORIDE
NDA #006134		 ORIG-1 METHADONE HYDROCHLORIDE HIKMA Approval
08/13/1947 METHADONE HYDROCHLORIDE
NDA #021624		 ORIG-1 METHADONE HYDROCHLORIDE MYLAN INSTITUTIONAL Approval
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