Description

The reference listed drugs selected by China National Medical Products Administration (NMPA) are reference products to which generic drugs should be equivalent in quality and therapeutic efficacy.

Related resource: Generic Drug Registration Application (ANDA) in China

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No. Drug Name Dosage Form Brand Name Strength MAH Note 1 Note 2 Batch
78-17   OPTIRAY 350 LIEBEL-FLARSHEIM CO LLC Original drug not imported to China US Orange Book The 78th Batch of Reference Listed Drugs
78-18   OPTIRAY 320 LIEBEL-FLARSHEIM CO LLC Original drug not imported to China US Orange Book The 78th Batch of Reference Listed Drugs
78-19   Lamisil Novartis Poland Sp. z o.o. Original drug not imported to China Approved in EU The 78th Batch of Reference Listed Drugs
78-20   Thyrozol Merck HealthcareGermany GmbH Original drug not imported to China Approved in EU The 78th Batch of Reference Listed Drugs
78-21   Periactin Alfasigma S.p.A/Alfasigma España, S.L Original drug not imported to China Approved in EU The 78th Batch of Reference Listed Drugs
78-22   Xarelto Bayer AG Original drug not imported to China Approved in EU The 78th Batch of Reference Listed Drugs
78-23   Xarelto Bayer AG Original drug not imported to China Approved in EU The 78th Batch of Reference Listed Drugs
78-24   Fluimucil Zambon Svizzera SA Original drug not imported to China Approved in Switzerland The 78th Batch of Reference Listed Drugs
78-25   Risperdal Janssen Pharmaceutical K.K. (ヤンセンファーマ株式会社) Original drug not imported to China Approved in Japan The 78th Batch of Reference Listed Drugs
78-26   Risperdal Janssen Pharmaceutical K.K. (ヤンセンファーマ株式会社) Original drug not imported to China Approved in Japan The 78th Batch of Reference Listed Drugs