Details for New Drug Application (NDA): 205740

NDA 205740 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 205740

Tradename:	ENTECAVIR
Applicant:	Hetero Labs Ltd V
Ingredient:	entecavir
Patents:	0

Pharmacology for NDA: 205740

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 205740

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTECAVIR	entecavir	TABLET;ORAL	205740	ANDA	Camber Pharmaceuticals, Inc.	31722-833	31722-833-30	30 TABLET in 1 BOTTLE (31722-833-30)
ENTECAVIR	entecavir	TABLET;ORAL	205740	ANDA	Camber Pharmaceuticals, Inc.	31722-833	31722-833-31	10 TABLET in 1 BLISTER PACK (31722-833-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Aug 21, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Aug 21, 2015	TE:	AB	RLD:	No

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