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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
April 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 16, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
04/01/1955 BICILLIN L-A
NDA #050141		 SUPPL-31 PENICILLIN G BENZATHINE KING PHARMS LLC Labeling Approval
04/06/1955 MESTINON
NDA #009829		 ORIG-1 PYRIDOSTIGMINE BROMIDE BAUSCH Type 1 - New Molecular Entity Approval
04/18/1955 PLAQUENIL
NDA #009768		 ORIG-1 HYDROXYCHLOROQUINE SULFATE CONCORDIA Type 1 - New Molecular Entity Approval
04/27/1955 SOLU-CORTEF
NDA #009866		 ORIG-1 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Type 2 - New Active Ingredient Approval
04/28/1955 MILTOWN
NDA #009698		 ORIG-1 MEPROBAMATE MEDPOINTE PHARM HLC Type 5 - New Formulation or New Manufacturer Approval
04/29/1955 EURAX
NDA #009112		 ORIG-1 CROTAMITON JOURNEY Type 3 - New Dosage Form Approval
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