FDA Guidance for Industry: Changes to an Approved NDA or ANDA, Revision 1

Title:
FDA Guidance for Industry: Changes to an Approved NDA or ANDA, Revision 1

https://www.gmp-compliance.org/files/guidemgr/Changes_ANDA.pdf

Origin/Publisher:

Drug Information Branch (HFD-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20856, Tel. 301 827 4573, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm077097.pdf

Document Type:
FDA Guidance for Industry
Content:
This FDA guideline contains important information for changes.

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