Unlock regulatory insights with Watson. Learn More

Industry Describing Product-Specific Bioequivalence Recommendations

Related Dockets FDA-2006-E-0260,FDA-2009-P-0208,FDA-2013-P-0608,FDA-2013-P-0664
KeyWord(s) Specific Products, Product-Specific Bioequivalence, Draft Guidances, cder, open, Bioequivalence Recommendations for Risperidone, Xiaoqiu Tang, Risperdal Consta Long-Acting Injection, BE, generic risperidone injection, Risperdal Consta, ANDA, NDA, 2015-197, 2015-298, Bioequivalence Recommendations for Progesterone, Draft Guidance for Industry, Availability, 2015-1246, 2016-467, 2016-483, 2016-469, 2016-1029, 2017-125
Short title Industry Describing Product-Specific Bioequivalence Recommendations
Docket Item Code D
Center CDER
VIEW ALL (69)Primary Documents
VIEW ALL (32) Supporting Documents