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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 206226

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NDA 206226 describes ENTECAVIR, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Breckenridge, Brightgene, Chartwell Rx, Cipla, 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 seventeen 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 206226

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Mar 26, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Mar 26, 2019	TE:		RLD:	No

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