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GUIDANCE DOCUMENT

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

Final

ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information

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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.