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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Dow
Citi
Farmers Insurance
Fish and Richardson
Medtronic
Julphar
Chubb
Fuji

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021797

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NDA 021797 describes BARACLUDE, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from one supplier. Additional details are available on the BARACLUDE profile page.

The generic ingredient in BARACLUDE 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 021797
Tradename:BARACLUDE
Applicant:Bristol Myers Squibb
Ingredient:entecavir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 021797
Suppliers and Packaging for NDA: 021797
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BARACLUDE entecavir TABLET;ORAL 021797 NDA E.R. Squibb & Sons, L.L.C. 0003-1611 N 0003-1611-12
BARACLUDE entecavir TABLET;ORAL 021797 NDA E.R. Squibb & Sons, L.L.C. 0003-1611 N 0003-1611-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Mar 29, 2005TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Mar 29, 2005TE:ABRLD:Yes

Expired US Patents for NDA 021797

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-001 Mar 29, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-002 Mar 29, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
Fuji
Teva
Healthtrust
Daiichi Sankyo
Farmers Insurance
Medtronic
Federal Trade Commission

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