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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 two patents protecting this drug. 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. Five suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.

Summary for NDA: 207155

Tradename:
EVOMELA
Applicant:
Spectrum Pharms
Ingredient:
melphalan hydrochloride
Patents:2
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)StrengthEQ 50MG BASE/VIAL
Approval Date:Mar 10, 2016TE:RLD:No
Patent:8,410,077Patent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:9,200,088Patent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Mar 10, 2023
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


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