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Generated: August 18, 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 Aurobindo Pharma Ltd, Teva Pharms Usa, Hetero Labs Ltd V, Zydus Pharms Usa Inc, Amneal Pharms, Cipla Ltd, Sandoz Inc, and Par Pharm Inc, and is included in eight 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 fifteen 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 NDA: 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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