Details for New Drug Application (NDA): 206217

NDA 206217 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 206217

Tradename:	ENTECAVIR
Applicant:	Aurobindo Pharma
Ingredient:	entecavir
Patents:	0

Pharmacology for NDA: 206217

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 206217

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTECAVIR	entecavir	TABLET;ORAL	206217	ANDA	American Health Packaging	60687-216	60687-216-25	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-216-25) / 1 TABLET in 1 BLISTER PACK (60687-216-95)
ENTECAVIR	entecavir	TABLET;ORAL	206217	ANDA	Aurobindo Pharma Limited	65862-841	65862-841-30	1 BOTTLE in 1 CARTON (65862-841-30) / 30 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Aug 26, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Aug 26, 2015	TE:	AB	RLD:	No

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