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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
May 1968

This report includes NDAs [including NDAs for new molecular entities (NMEs)] and BLAs (including new biological products) approved for the first time during the selected month. Original BLA/NDA approvals by CBER are not included in Drugs@FDA. This report does not include approved NDA or BLA supplements, approved ANDAs, or tentatively approved ANDAs/NDAs.

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 06, 2022.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
05/09/1968 PATHOCIL
NDA #050011
05/24/1968 HIPPURAN I 131
NDA #016666
IODOHIPPURATE SODIUM I-131 Type 5 - New Formulation or New Manufacturer Standard MALLINCKRODT
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