Code of Federal Regulations · Subpart

Subpart C — Abbreviated Applications

21 C.F.R. pt. 314, subpt. C

• § 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