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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 27, 2025
All Titles
Title 21
Chapter I
Part 314
Subpart C - Subpart C—Abbreviated Applications
§ 314.92 - Drug products for which abbreviated applications may be submitted.
§ 314.93 - Petition to request a change from a listed drug.
§ 314.94 - Content and format of an ANDA.
§ 314.95 - Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
§ 314.96 - Amendments to an unapproved ANDA.
§ 314.97 - Supplements and other changes to an approved ANDA.
§ 314.98 - Postmarketing reports.
§ 314.99 - Other responsibilities of an applicant of an ANDA.
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