Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021004

5MG/ML Marketing Status: Prescription

Active Ingredient: LAMIVUDINE
Proprietary Name: EPIVIR-HBV
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021004
Product Number: 001
Approval Date: Dec 8, 1998
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

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