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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 206523

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NDA 206523 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 206523

Tradename:	MELPHALAN HYDROCHLORIDE
Applicant:	Avet Lifesciences
Ingredient:	melphalan hydrochloride
Patents:	0

Suppliers and Packaging for NDA: 206523

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	206523	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-355	23155-355-41	1 KIT in 1 CARTON (23155-355-41) * 10 mL in 1 VIAL (23155-353-31) * 10 mL in 1 VIAL (23155-354-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/VIAL
Approval Date:	Oct 29, 2024	TE:	AP	RLD:	No

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