Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214383

PEPAXTO (MELPHALAN FLUFENAMIDE HYDROCHLORIDE)
EQ 20MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: MELPHALAN FLUFENAMIDE HYDROCHLORIDE
Proprietary Name: PEPAXTO
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 20MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214383
Product Number: 001
Approval Date: Feb 26, 2021
Applicant Holder Full Name: ONCOPEPTIDES AB
Marketing Status:  Prescription
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