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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216857

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NDA 216857 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 216857

Tradename:	ENTECAVIR
Applicant:	Conba Usa
Ingredient:	entecavir
Patents:	0

Pharmacology for NDA: 216857

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 216857

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTECAVIR	entecavir	TABLET;ORAL	216857	ANDA	Cameron Pharmaceuticals	42494-457	42494-457-30	30 TABLET in 1 BOTTLE (42494-457-30)
ENTECAVIR	entecavir	TABLET;ORAL	216857	ANDA	Cameron Pharmaceuticals	42494-458	42494-458-30	30 TABLET in 1 BOTTLE (42494-458-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Dec 23, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Dec 23, 2024	TE:	AB	RLD:	No

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