Details for New Drug Application (NDA): 208721

NDA 208721 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 208721

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

Pharmacology for NDA: 208721

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 208721

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTECAVIR	entecavir	TABLET;ORAL	208721	ANDA	Breckenridge Pharmaceutical, Inc.	51991-895	51991-895-33	30 TABLET in 1 BOTTLE, PLASTIC (51991-895-33)
ENTECAVIR	entecavir	TABLET;ORAL	208721	ANDA	Breckenridge Pharmaceutical, Inc.	51991-896	51991-896-33	30 TABLET in 1 BOTTLE, PLASTIC (51991-896-33)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Mar 15, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Mar 15, 2018	TE:	AB	RLD:	No

Complete Access Available with Subscription