21 CFR Part 314, 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.
Source:
57 FR 17983, Apr. 28, 1992, unless otherwise noted.