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CDER Freedom of Information

New Drug Approval Packages

These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office. The packages have been redacted or edited to remove confidential information. Click on the product name to view the approval packages in Adobe Acrobat format. For further information about Adobe Acrobat and download instructions, click here.



Also see: Generic Drug Approval Packages

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FDA/Center for Drug Evaluation and Research
Last Updated: February 27, 2003
Originator: OTCOM/DLIS