U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Changes to an Approved NDA or ANDA: Questions and Answers
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Changes to an Approved NDA or ANDA: Questions and Answers Guidance for Industry January 2001

Download the Final Guidance Document
Final
Docket Number:
FDA-1999-D-0049
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This document provides questions and answers relating to the guidance on Changes to an Approved NDA or ANDA (the guidance).2 The questions are based on those posed to CDER by applicants. The questions and answers are presented using subject headings that correspond to the table of contents in the guidance

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1999-D-0049.

Back to Top