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Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205740

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NDA 205740 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 fourteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Summary for 205740
Applicant:Hetero Labs Ltd V
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 205740
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 N 31722-833-32
ENTECAVIR entecavir TABLET;ORAL 205740 ANDA Camber Pharmaceuticals, Inc. 31722-833 N 31722-833-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Aug 21, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 21, 2015TE:ABRLD:No

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