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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 207809


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NDA 207809 describes MELPHALAN, which is a drug marketed by Alvogen, 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 eighteen NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the MELPHALAN profile page.

The generic ingredient in MELPHALAN 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 207809
Tradename:MELPHALAN
Applicant:Alvogen
Ingredient:melphalan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207809
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 207809
Suppliers and Packaging for NDA: 207809
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MELPHALAN melphalan TABLET;ORAL 207809 ANDA Alvogen Inc. 47781-200 47781-200-50 50 TABLET in 1 BOTTLE, GLASS (47781-200-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Mar 22, 2017TE:RLD:No

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