Subpart C - Abbreviated Applications

Applications for FDA Approval to Market a New Drug

Documents and Forms

Document Name Document Type
GFI Good-ANDA-Submission-Practices-Guidance-for-Industry JAN 2018.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/good-anda-submission-practices-guidance-industry Other-Agency Guidance

Information Collection (IC) Details