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Serving leading biopharmaceutical companies globally:

McKesson
Chinese Patent Office
US Army
Novartis
Fish and Richardson
Harvard Business School
Covington
Argus Health
Mallinckrodt
Julphar

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206217

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NDA 206217 describes ENTECAVIR, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma Ltd, Cipla Ltd, Hetero Labs Ltd V, Par Pharm Inc, Prinston Inc, Sandoz Inc, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in ten NDAs. It is available from thirteen suppliers. Additional details are available on the ENTECAVIR profile page.

The generic ingredient in ENTECAVIR is entecavir. There are sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.

Summary for 206217

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 206217

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 LUCID PHARMA LLC 52343-147 52343-147-30 30 CARTON in 1 BOTTLE (52343-147-30) > 1 TABLET in 1 CARTON
ENTECAVIR entecavir TABLET;ORAL 206217 ANDA LUCID PHARMA LLC 52343-148 52343-148-30 30 CARTON in 1 BOTTLE (52343-148-30) > 1 TABLET in 1 CARTON

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Aug 26, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 26, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Novartis
Cipla
Merck
Dow
Accenture
Moodys
Argus Health
Baxter
Fuji
Daiichi Sankyo

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