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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210947

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NDA 210947 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 210947

Tradename:	MELPHALAN HYDROCHLORIDE
Applicant:	Novast Labs
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:	Feb 18, 2020	TE:		RLD:	No

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