§ 314.99 Other responsibilities of an applicant of an ANDA

(a) An applicant must comply with the requirements of § 314.65 regarding withdrawal by the applicant of an unapproved ANDA and § 314.72 regarding a change in ownership of an ANDA.

(b) An applicant may ask FDA to waive under this section any requirement that applies to the applicant under §§ 314.92 through 314.99 . The applicant must comply with the requirements for a waiver under § 314.90 . If FDA grants the applicant's waiver request with respect to a requirement under §§ 314.92 through 314.99 , the waived requirement will not constitute a basis for refusal to approve an ANDA under § 314.127 .

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FDA guidance that cites § 314.99

• Determining Whether to Submit an ANDA or a 505(b)(2) Application draft 17 Aug 2026
• Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry 17 Nov 2025
• Good ANDA Submission Practices Guidance for Industry 26 Jan 2022
• Determining Whether to Submit an ANDA or a 505(b)(2) Application 10 May 2019
• ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry draft 3 Oct 2017
• ANDA Submissions -- Refuse-to-Receive Standards Rev.2 28 Dec 2016
• Sample formats for Form FDA 356h_2011 draft 2 Feb 2011

Amendment history

Federal Register documents that created or amended this section.

• 50 FR 7493 22 Feb 1985
• 57 FR 17983 28 Apr 1992
• 81 FR 69653 6 Oct 2016