Details for New Drug Application (NDA): 208782

NDA 208782 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 208782

Tradename:	ENTECAVIR
Applicant:	Prinston Inc
Ingredient:	entecavir
Patents:	0

Pharmacology for NDA: 208782

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 208782

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTECAVIR	entecavir	TABLET;ORAL	208782	ANDA	Solco Healthcare LLC	43547-436	43547-436-03	30 TABLET, FILM COATED in 1 BOTTLE (43547-436-03)
ENTECAVIR	entecavir	TABLET;ORAL	208782	ANDA	Solco Healthcare LLC	43547-436	43547-436-09	90 TABLET, FILM COATED in 1 BOTTLE (43547-436-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Oct 10, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 10, 2017	TE:		RLD:	No

Complete Access Available with Subscription