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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
November 1959

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 May 04, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
11/04/1959 NORFLEX
NDA #012157		 ORIG-1 ORPHENADRINE CITRATE BAUSCH Type 2 - New Active Ingredient Approval
11/09/1959 ISORDIL
NDA #012093		 ORIG-1 ISOSORBIDE DINITRATE BAUSCH Type 1 - New Molecular Entity Approval
11/16/1959 CYTOXAN
NDA #012141		 ORIG-1 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Type 1 - New Molecular Entity Approval
11/16/1959 CYTOXAN
NDA #012142		 ORIG-1 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Type 2 - New Active Ingredient Approval
11/16/1959 CYTOXAN (LYOPHILIZED)
NDA #012142		 ORIG-1 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Type 2 - New Active Ingredient Approval
11/16/1959 LYOPHILIZED CYTOXAN
NDA #012142		 ORIG-1 CYCLOPHOSPHAMIDE BAXTER HLTHCARE Type 2 - New Active Ingredient Approval
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