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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 212201

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NDA 212201 describes ENTECAVIR, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Breckenridge, Brightgene, Chartwell Rx, Cipla, Conba Usa, Hetero Labs Ltd V, Prinston Inc, Rising, Sunshine, Swiss Pharm, Teva Pharms Usa, Yaopharma Co Ltd, Yung Shin Pharm, and Zydus Pharms, and is included in eighteen NDAs. It is available from fifteen suppliers. Additional details are available on the ENTECAVIR profile page.

The generic ingredient in ENTECAVIR is entecavir. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.

Summary for 212201

Tradename:	ENTECAVIR
Applicant:	Yaopharma Co Ltd
Ingredient:	entecavir
Patents:	0

Pharmacology for NDA: 212201

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 212201

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTECAVIR	entecavir	TABLET;ORAL	212201	ANDA	Yaopharma Co., Ltd.	50771-013	50771-013-01	30 TABLET, FILM COATED in 1 BOTTLE (50771-013-01)
ENTECAVIR	entecavir	TABLET;ORAL	212201	ANDA	Yaopharma Co., Ltd.	50771-013	50771-013-02	90 TABLET, FILM COATED in 1 BOTTLE (50771-013-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Nov 4, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Nov 4, 2019	TE:		RLD:	No

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