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Generated: September 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206872

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NDA 206872 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 seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Summary for 206872
Tradename:ENTECAVIR
Applicant:Cipla Ltd
Ingredient:entecavir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206872
Suppliers and Packaging for NDA: 206872
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTECAVIR entecavir TABLET;ORAL 206872 ANDA NorthStar RxLLC 16714-717 16714-717-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-717-01)
ENTECAVIR entecavir TABLET;ORAL 206872 ANDA NorthStar RxLLC 16714-718 16714-718-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-718-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Dec 6, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 6, 2016TE:ABRLD:No

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