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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Johnson and Johnson
Covington
Moodys
Citi
McKinsey
QuintilesIMS
US Army
Cerilliant

Generated: February 19, 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 sixteen drug master file entries for this compound. Fifteen 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 0003-1611-13
BARACLUDE entecavir TABLET;ORAL 021797 NDA E.R. Squibb & Sons, L.L.C. 0003-1611 N 0003-1611-12

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

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
Cerilliant
AstraZeneca
Mallinckrodt
Fish and Richardson
Covington
Fuji
Moodys

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