Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209323

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NDA 209323 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, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Ph Health, Sagent Pharms Inc, and Uswm, and is included in eighteen NDAs. It is available from thirteen suppliers. Additional details are available on the MELPHALAN HYDROCHLORIDE profile page.

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

Summary for 209323

Tradename:	MELPHALAN HYDROCHLORIDE
Applicant:	Actavis Llc
Ingredient:	melphalan hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Mar 6, 2020	TE:		RLD:	No

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