Federal (United States) · Regulations
Subpart C — Abbreviated Applications
6 sections
6 sections
- 21 C.F.R. § 314.93Petition to request a change from a listed drug.
- 21 C.F.R. § 314.95Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
- 21 C.F.R. § 314.96Amendments to an unapproved ANDA.
- 21 C.F.R. § 314.97Supplements and other changes to an approved ANDA.
- 21 C.F.R. § 314.98Postmarketing reports.
- 21 C.F.R. § 314.99Other responsibilities of an applicant of an ANDA.