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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
May 1968

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 03, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
05/09/1968 PATHOCIL
NDA #050011
ORIG-1 DICLOXACILLIN SODIUM WYETH AYERST Approval
05/24/1968 HIPPURAN I 131
NDA #016666
ORIG-1 IODOHIPPURATE SODIUM I-131 MALLINCKRODT Type 5 - New Formulation or New Manufacturer Approval
05/27/1968 LINCOCIN
NDA #050317
SUPPL-54 LINCOMYCIN HYDROCHLORIDE PFIZER Labeling Approval
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