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Last Updated: July 5, 2020

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Details for New Drug Application (NDA): 020207

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NDA 020207 describes ALKERAN, which is a drug marketed by Apotex and is included in two NDAs. It is available from one supplier. Additional details are available on the ALKERAN profile page.

The generic ingredient in ALKERAN is melphalan. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the melphalan profile page.
Summary for 020207
Ingredient:melphalan hydrochloride
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020207
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALKERAN melphalan hydrochloride INJECTABLE;INJECTION 020207 NDA ApoPharma USA, Inc. 52609-3001 52609-3001-0 1 KIT in 1 CARTON (52609-3001-0) * 10 mL in 1 VIAL, SINGLE-DOSE (52609-3002-0) * 10 mL in 1 VIAL, SINGLE-USE (52609-3003-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 18, 1992TE:APRLD:Yes

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