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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
QuintilesIMS
Farmers Insurance
Chubb
AstraZeneca
Moodys
Merck
Medtronic
Cantor Fitzgerald
US Department of Justice

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206652

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NDA 206652 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 206652
Tradename:ENTECAVIR
Applicant:Amneal Pharms
Ingredient:entecavir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 206652
Suppliers and Packaging for NDA: 206652
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTECAVIR entecavir TABLET;ORAL 206652 ANDA Marlex Pharmaceuticals Inc 10135-615 10135-615-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-615-30)
ENTECAVIR entecavir TABLET;ORAL 206652 ANDA Marlex Pharmaceuticals Inc 10135-616 10135-616-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-616-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Nov 12, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Nov 12, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Healthtrust
Novartis
McKinsey
Deloitte
UBS
Boehringer Ingelheim
Chinese Patent Office
Queensland Health
Moodys

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