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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201532

1MG/2ML (0.5MG/ML)
Marketing Status: Prescription
Active Ingredient: ERIBULIN MESYLATE
Proprietary Name: HALAVEN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1MG/2ML (0.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N201532
Product Number: 001
Approval Date: Nov 15, 2010
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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