Last Updated: November 8, 2026

Details for New Drug Application (NDA): 204773

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NDA 204773 describes MELPHALAN HYDROCHLORIDE, which is a drug marketed by Actavis Llc, Almaject, Avet Lifesciences, Bpi Labs, Dr Reddys, Fresenius Kabi Usa, Gland, Hetero Labs, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Ph Health, Quagen, 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 204773

Tradename:	MELPHALAN HYDROCHLORIDE
Applicant:	Ph Health
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:	Aug 22, 2016	TE:		RLD:	No

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