Last Updated: November 8, 2026

Details for New Drug Application (NDA): 212106

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NDA 212106 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, Pharmadax, Prinston Inc, Rising, Sunshine, 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 is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.

Summary for 212106

Tradename:	ENTECAVIR
Applicant:	Pharmadax
Ingredient:	entecavir
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Aug 10, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Aug 10, 2020	TE:		RLD:	No

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