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. ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information Guidance for Industry July 2007

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2004-D-0182
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Chemistry, manufacturing, and controls (CMC) information must be submitted to support the approval of an abbreviated new drug application (ANDA). This guidance is intended to assist applicants with the submission of ANDAs when a drug substance exists in polymorphic forms.

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-2004-D-0182.

Back to Top