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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
December 1953

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 28, 2023.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
12/03/1953 CORTRIL
NDA #009127		 ORIG-1 HYDROCORTISONE PFIZER Type 5 - New Formulation or New Manufacturer Approval
12/04/1953 GANTRISIN
NDA #009182		 ORIG-1 SULFISOXAZOLE ACETYL ROCHE Type 2 - New Active Ingredient Approval
12/04/1953 GANTRISIN PEDIATRIC
NDA #009182		 ORIG-1 SULFISOXAZOLE ACETYL ROCHE Type 2 - New Active Ingredient Approval
12/04/1953 LIPO GANTRISIN
NDA #009182		 ORIG-1 SULFISOXAZOLE ACETYL ROCHE Type 2 - New Active Ingredient Approval
12/07/1953 METHOTREXATE SODIUM
NDA #008085		 ORIG-1 METHOTREXATE SODIUM STRIDES PHARMA Type 1 - New Molecular Entity Approval
12/09/1953 BICILLIN L-A
NDA #050141		 SUPPL-20 PENICILLIN G BENZATHINE KING PHARMS LLC Manufacturing (CMC) Approval
12/09/1953 CHLOROMYCETIN HYDROCORTISONE
NDA #050202		 ORIG-1 CHLORAMPHENICOL; HYDROCORTISONE ACETATE PARKEDALE Approval
12/22/1953 HYDROXYSTILBAMIDINE ISETHIONATE
NDA #009166		 ORIG-1 HYDROXYSTILBAMIDINE ISETHIONATE SANOFI AVENTIS US Type 3 - New Dosage Form Approval
12/23/1953 FURADANTIN
NDA #009175		 ORIG-1 NITROFURANTOIN CASPER PHARMA LLC Type 3 - New Dosage Form Approval
12/24/1953 DELATESTRYL
NDA #009165		 ORIG-1 TESTOSTERONE ENANTHATE ENDO PHARMS Type 2 - New Active Ingredient Approval
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