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Bookmark or Share- Abbreviated New Drug Application - WikipediaAn Abbreviated New Drug Application ( ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug . The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.
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- Abbreviated New Drug Application (ANDA) Forms and Submission ...Abbreviated New Drug Application (ANDA) Forms and Submission Requirements | FDA. The FDA aspires to assist applicants in developing abbreviated new drug applications (ANDAs). To facilitate...
- Abbreviated New Drug Application (ANDA) | FDAAn abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may...
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