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Generated: December 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205824

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NDA 205824 describes ENTECAVIR, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma Ltd, Breckenridge Pharm, Casi Pharms Inc, Cipla, 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 eighteen 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 205824
Applicant:Accord Hlthcare
Formulation / Manufacturing:see details
Pharmacology for NDA: 205824
Suppliers and Packaging for NDA: 205824
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTECAVIR entecavir TABLET;ORAL 205824 ANDA Accord Healthcare Inc. 16729-388 16729-388-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-388-10)
ENTECAVIR entecavir TABLET;ORAL 205824 ANDA Accord Healthcare Inc. 16729-389 16729-389-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-389-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Aug 25, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 25, 2017TE:ABRLD:No

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