Description

The reference listed drugs selected by China's National Medical Products Administration (NMPA) are reference products to which new generic drugs are compared to demonstrate bioequivalence. 

A generic drug product proposed for marketing authorization needs to be evaluated by NMPA to show consistency with the reference product in quality and efficacy.

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No. Drug Name Dosage Form Brand Name Strength MAH Note 1 Note 2 Batch
56-1  Fluimucil (富露施) Zambon Italia S.R.L Internationally recognized to be equivalent to the original drug Imported to China; internationally recognized to be equivalent to the original drug The 56th Batch of Reference Listed Drugs
56-2  Netspot Advanced Accelerator Applications Usa Inc Original drug not imported to China US Orange Book The 56th Batch of Reference Listed Drugs
56-3  Netspot Advanced Accelerator Applications Usa Inc Original drug not imported to China US Orange Book The 56th Batch of Reference Listed Drugs
56-4  Eligard Tolmar Pharmaceuticals, Inc. Original drug not imported to China US Orange Book The 56th Batch of Reference Listed Drugs
56-5  Promacta Kit Novartis Pharmaceuticals Corporation Original drug not imported to China US Orange Book The 56th Batch of Reference Listed Drugs
56-6  Promacta Kit Novartis Pharmaceuticals Corporation Original drug not imported to China US Orange Book The 56th Batch of Reference Listed Drugs
56-7  Cardizem La Bausch Health Us Llc Original drug not imported to China US Orange Book The 56th Batch of Reference Listed Drugs
56-8  Cardizem La Bausch Health Us Llc Original drug not imported to China US Orange Book The 56th Batch of Reference Listed Drugs
56-9  Cardizem La Bausch Health Us Llc Original drug not imported to China US Orange Book The 56th Batch of Reference Listed Drugs
56-10  Cardizem La Bausch Health Us Llc Original drug not imported to China US Orange Book The 56th Batch of Reference Listed Drugs