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Serving leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Fish and Richardson

Generated: December 16, 2017

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, Mylan Institutional, Par Sterile Products, Sagent Pharms, and West-ward Pharms Int, and is included in six NDAs. It is available from five 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. Seven suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.

Summary for 204773

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 42023-149-01 10 mL in 1 VIAL (42023-149-01)

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Fish and Richardson
Federal Trade Commission
Daiichi Sankyo
Queensland Health

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