Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021797

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BARACLUDE (ENTECAVIR)
0.5MG
Marketing Status: Prescription

Active Ingredient: ENTECAVIR
Proprietary Name: BARACLUDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021797
Product Number: 001
Approval Date: Mar 29, 2005
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Prescription
Patent and Exclusivity Information

BARACLUDE (ENTECAVIR)
1MG
Marketing Status: Prescription

Active Ingredient: ENTECAVIR
Proprietary Name: BARACLUDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021797
Product Number: 002
Approval Date: Mar 29, 2005
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Prescription
Patent and Exclusivity Information