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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021798

BARACLUDE (ENTECAVIR)
0.05MG/ML
Marketing Status: Prescription
Active Ingredient: ENTECAVIR
Proprietary Name: BARACLUDE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 0.05MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021798
Product Number: 001
Approval Date: Mar 29, 2005
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Prescription
Patent and Exclusivity Information
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