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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090270

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NDA 090270 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 090270

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 090270

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090270 ANDA Mylan Institutional LLC 67457-195 67457-195-01 1 KIT in 1 CARTON (67457-195-01) * 10 mL in 1 VIAL, GLASS (67457-193-50) * 10 mL in 1 VIAL, GLASS (67457-194-10)
MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090270 ANDA Mylan Institutional LLC 67457-215 67457-215-01 1 KIT in 1 CARTON (67457-215-01) * 10 mL in 1 VIAL, GLASS (67457-213-50) * 10 mL in 1 VIAL, GLASS (67457-214-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:Jun 9, 2009TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Julphar
Colorcon
Cipla
Cantor Fitzgerald
Cerilliant
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McKinsey
QuintilesIMS
Daiichi Sankyo
McKesson

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