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- eCFR :: 21 CFR 314.94 -- Content and format of an ANDA.§ 314.94 Content and format of an ANDA. ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their preparation.
- 5200.14 Rev. 1Filing Review of Abbreviated New Drug ApplicationsThis MAPP outlines the policies and procedures for the conduct of a filing review of an abbreviated new drug application (ANDA) by the Division of Filing Review (DFR), Office of Regulatory...
- Abbreviated New Drug Application (ANDA) Forms and Submission ...ANDA Forms In order to submit a complete ANDA, applicants should review the following forms and prepare all that are required for your specific application.
- Abbreviated New Drug Application (ANDA) : PharmaguidelineAn Abbreviated New Drug Application (ANDA) refers to a type of data submitted to the U.S. Food and Drug Administration (FDA) for the purposes of reviewing and approving potential generic drug product.
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