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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
September 1962

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 September 20, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
09/13/1962 URACIL MUSTARD
NDA #012892
ORIG-1 URACIL MUSTARD SHIRE Type 1 - New Molecular Entity Approval
09/14/1962 DECLOMYCIN
NDA #050257
SUPPL-15 DEMECLOCYCLINE HYDROCHLORIDE LEDERLE Labeling Approval
09/17/1962 DEXACORT
NDA #013413
ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE UCB INC Type 3 - New Dosage Form Approval
09/20/1962 BICILLIN C-R
NDA #050138
SUPPL-19 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
09/20/1962 BICILLIN C-R
NDA #050138
SUPPL-21 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
09/20/1962 BICILLIN C-R 900/300
NDA #050138
SUPPL-19 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
09/20/1962 BICILLIN C-R 900/300
NDA #050138
SUPPL-21 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
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