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Generated: November 19, 2018

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Details for New Drug Application (NDA): 207155

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NDA 207155 describes EVOMELA, which is a drug marketed by Spectrum Pharms and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EVOMELA profile page.

The generic ingredient in EVOMELA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
Summary for 207155
Tradename:EVOMELA
Applicant:Spectrum Pharms
Ingredient:melphalan hydrochloride
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 207155
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 207155
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EVOMELA melphalan hydrochloride POWDER;IV (INFUSION) 207155 NDA Spectrum Pharmaceuticals, Inc. 68152-109 68152-109-00 1 VIAL in 1 CARTON (68152-109-00) > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)StrengthEQ 50MG BASE/VIAL
Approval Date:Mar 10, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 10, 2023
Regulatory Exclusivity Use:FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA
Patent:➤ Try a Free TrialPatent Expiration:Jan 30, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?

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