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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
November 1963

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 April 21, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
11/12/1963 DECLOMYCIN
NDA #050257
SUPPL-20 DEMECLOCYCLINE HYDROCHLORIDE LEDERLE Labeling Approval
11/12/1963 DECLOMYCIN
NDA #050262
SUPPL-27 DEMECLOCYCLINE HYDROCHLORIDE LEDERLE Labeling Approval
11/15/1963 VALIUM
NDA #013263
ORIG-1 DIAZEPAM WAYLIS THERAP Type 1 - New Molecular Entity Approval
11/15/1963 BICILLIN C-R
NDA #050138
SUPPL-51 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
11/15/1963 BICILLIN C-R 900/300
NDA #050138
SUPPL-51 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
11/21/1963 DECLOMYCIN
NDA #050262
SUPPL-19 DEMECLOCYCLINE HYDROCHLORIDE LEDERLE Manufacturing (CMC) Approval
11/22/1963 BICILLIN L-A
NDA #050141
SUPPL-80 PENICILLIN G BENZATHINE KING PHARMS LLC Labeling Approval
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