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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 090303

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NDA 090303 describes MELPHALAN HYDROCHLORIDE, which is a drug marketed by Actavis Llc, Almaject, Arthur Grp, Bpi Labs, Dr Reddys, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hetero Labs, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Sagent Pharms Inc, and Uswm, and is included in seventeen 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. Sixteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.

Summary for 090303

Tradename:	MELPHALAN HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	melphalan hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/VIAL
Approval Date:	Oct 28, 2010	TE:	AP	RLD:	No

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