FDA Listing of Authorized Generics

CGMP/Finished Pharmaceuticals/Adulterated

FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin-aspart-szij), a biosimilar to its reference product Novolog (insulin aspart), to improve glycemic control in adults and children with diabetes mellitus.

InnoStar Bio-Tech Nantong Company, Ltd – 11/1/2024. Country: United States. Record Type: Response to Form 483

CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)Draft page

FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions