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