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Last Updated: December 12, 2025

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. 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. Additional details are available on the melphalan profile page.

Summary for 020207

Tradename:	ALKERAN
Applicant:	Apotex
Ingredient:	melphalan hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 18, 1992	TE:		RLD:	Yes

Expired US Patents for NDA 020207

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	ALKERAN	melphalan hydrochloride	INJECTABLE;INJECTION	020207-001	Nov 18, 1992	4,997,651	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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