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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207155

EVOMELA (MELPHALAN HYDROCHLORIDE)
EQ 50MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: MELPHALAN HYDROCHLORIDE
Proprietary Name: EVOMELA
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 50MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207155
Product Number: 001
Approval Date: Mar 10, 2016
Applicant Holder Full Name: ACROTECH BIOPHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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