Abbreviated Applications | Midpage

Collections
Code of Federal Regulations

Subpart C

Abbreviated Applications

314.92Drug products for which abbreviated applications may be submitted.314.93Petition to request a change from a listed drug.314.94Content and format of an ANDA.314.95Notice of certification of invalidity, unenforceability, or noninfringement of a patent.314.96Amendments to an unapproved ANDA.314.97Supplements and other changes to an approved ANDA.314.98Postmarketing reports.314.99Other responsibilities of an applicant of an ANDA.