Get Anda Filing Checklist

FDA Commissioner Scott Gottlieb said in a statement: "It currently takes on average about four cycles for an ANDA to reach approval – not necessarily because the product will not meet our standards, but sometimes because the application is missing information necessary to demonstrate that it does.

Electronic Submissions All ANDA submissions MUST be in eCTD format. eCTD submission sizes 10 GB or less must use the FDA Electronic Submission Gateway (ESG). If an eCTD submission is greater than 10 GB, it may be submitted via physical media (DVD/USB Drive) to the CDER Document Room or via ESG.

In obtaining approval, the ANDA applicant must demonstrate, among other things: (1) that the proposed generic drug is the same as the RLD; (2) that the proposed generic drug is bioequivalent to the RLD; and (3) if in vivo bioequivalence studies are required for approval of the ANDA, that the proposed generic drug is ...

ANDA Forms Filing Review of ANDAs MAPP including filing checklist (PDF - 521KB) Form FDA-356h: Application to Market a New Drug, Biologic, or Antibiotic Drug for Human Use (PDF - 2.3MB) Instructions for using Form FDA-356h (PDF - 129KB) Instructions for Completing Form FDA 3794 (Generic Drug User Fee Cover Sheet)

For PET ANDAs, the Agency recommends a minimum of three batches at or near the upper end of the proposed radio-concentration. If different synthesizers (methods of synthesis) are used, three batches from each method of synthesis at or near the upper end of the proposed radio-concentration are recommended.

An Abbreviated New Drug Application (ANDA) contains data which is submitted to the FDA for the review and potential approval of a generic drug product whereas a New Drug Application (NDA) is the application through which sponsors formally propose the approval of a new pharmaceutical drug.

New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products.

An 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 manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.