Details for New Drug Application (NDA): 208195

NDA 208195 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 208195

Tradename:	ENTECAVIR
Applicant:	Yung Shin Pharm
Ingredient:	entecavir
Patents:	0

Pharmacology for NDA: 208195

Mechanism of Action

Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 208195

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTECAVIR	entecavir	TABLET;ORAL	208195	ANDA	Golden State Medical Supply, Inc.	51407-589	51407-589-30	30 TABLET in 1 BOTTLE, PLASTIC (51407-589-30)
ENTECAVIR	entecavir	TABLET;ORAL	208195	ANDA	Carlsbad Technology, Inc.	61442-311	61442-311-30	30 TABLET in 1 BOTTLE, PLASTIC (61442-311-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Nov 10, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Nov 10, 2021	TE:	AB	RLD:	No

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