ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information Guidance for Industry July 2007
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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:
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.