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