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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 eighteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Summary for 021797
Applicant:Bristol Myers Squibb
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 0003-1611-12 1 BOTTLE in 1 CARTON (0003-1611-12) > 30 TABLET, FILM COATED in 1 BOTTLE
BARACLUDE entecavir TABLET;ORAL 021797 NDA E.R. Squibb & Sons, L.L.C. 0003-1612 0003-1612-12 1 BOTTLE in 1 CARTON (0003-1612-12) > 30 TABLET, FILM COATED in 1 BOTTLE
Paragraph IV (Patent) Challenges for 021797
Tradename Dosage Ingredient NDA Submissiondate
BARACLUDE TABLET;ORAL entecavir 021797 2010-06-14

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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