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Generated: May 25, 2018

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, Breckenridge Pharm, Casi Pharms Inc, Cipla Ltd, Hetero Labs Ltd V, Par Pharm Inc, Prinston Inc, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in eleven NDAs. It is available from sixteen suppliers. Additional details are available on the ENTECAVIR profile page.

The generic ingredient in ENTECAVIR is entecavir. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Summary for 206217
Tradename:ENTECAVIR
Applicant:Aurobindo Pharma Ltd
Ingredient:entecavir
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 N 52343-147-30
ENTECAVIR entecavir TABLET;ORAL 206217 ANDA LUCID PHARMA LLC 52343-148 N 52343-148-30

Profile for product number 001

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

Profile for product number 002

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

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