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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 207032

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NDA 207032 describes MELPHALAN HYDROCHLORIDE, which is a drug marketed by Actavis Llc, Almaject, Arthur Grp, Avet Lifesciences, Bpi Labs, Dr Reddys, Fresenius Kabi Usa, Gland, Hetero Labs, Hikma, Meitheal, Mylan Institutional, Novast Labs, Ph Health, Sagent Pharms Inc, and Uswm, and is included in eighteen NDAs. It is available from fourteen suppliers. Additional details are available on the MELPHALAN HYDROCHLORIDE profile page.

The generic ingredient in MELPHALAN HYDROCHLORIDE is melphalan hydrochloride. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.

Summary for 207032

Tradename:	MELPHALAN HYDROCHLORIDE
Applicant:	Uswm
Ingredient:	melphalan hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/VIAL
Approval Date:	May 3, 2019	TE:		RLD:	No

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