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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021798

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NDA 021798 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 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 021798
Tradename:BARACLUDE
Applicant:Bristol Myers Squibb
Ingredient:entecavir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021798
Suppliers and Packaging for NDA: 021798
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BARACLUDE entecavir SOLUTION;ORAL 021798 NDA E.R. Squibb & Sons, L.L.C. 0003-1614 0003-1614-12 1 BOTTLE in 1 CARTON (0003-1614-12) > 210 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength0.05MG/ML
Approval Date:Mar 29, 2005TE:RLD:Yes

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