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Last Updated: March 19, 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, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Par Sterile Products, Sagent Pharms Inc, Uswm, and Apotex, and is included in seventeen NDAs. It is available from twelve suppliers. There is one patent protecting this drug. 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. Fourteen 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
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:Oct 28, 2010TE:APRLD:No

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