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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 October 31, 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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