Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Chinese Patent Office
Harvard Business School

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204773

« Back to Dashboard

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.