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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 215024

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NDA 215024 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 215024

Tradename:	MELPHALAN HYDROCHLORIDE
Applicant:	Hetero Labs
Ingredient:	melphalan hydrochloride
Patents:	0

Suppliers and Packaging for NDA: 215024

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	215024	ANDA	Camber Pharmaceuticals, Inc.	31722-362	31722-362-31	1 KIT in 1 CARTON (31722-362-31) * 10 mL in 1 VIAL, SINGLE-DOSE (31722-360-31) * 10 mL in 1 VIAL, SINGLE-USE (31722-361-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/VIAL
Approval Date:	May 23, 2024	TE:	AP	RLD:	No

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