Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
December 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 January 23, 2020.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
12/05/1955 RITALIN
NDA #010187
ORIG-1 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Type 3 - New Dosage Form Approval
12/06/1955 BICILLIN C-R
NDA #050138
SUPPL-15 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
12/06/1955 BICILLIN C-R 900/300
NDA #050138
SUPPL-15 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval

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