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.