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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021897

VIVITROL (NALTREXONE)
380MG/VIAL
Marketing Status: Prescription
Active Ingredient: NALTREXONE
Proprietary Name: VIVITROL
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 380MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021897
Product Number: 001
Approval Date: Apr 13, 2006
Applicant Holder Full Name: ALKERMES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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