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Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204773

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NDA 204773 describes MELPHALAN HYDROCHLORIDE, which is a drug marketed by Actavis Llc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Mylan Institutional, Par Sterile Products, Sagent Pharms, and West-ward Pharms Int, and is included in eight NDAs. It is available from seven 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. Nine suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
Summary for 204773
Applicant:Par Sterile Products
Ingredient:melphalan hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 204773
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 204773
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 204773 ANDA Par Pharmaceutical, Inc. 42023-149 N 42023-149-01

Profile for product number 001

Approval Date:Aug 22, 2016TE:APRLD:No

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