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Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090299

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NDA 090299 describes MELPHALAN HYDROCHLORIDE, which is a drug marketed by West-ward Pharms Int, Actavis Llc, Mylan Institutional, Par Sterile Products, and Sagent Pharms, 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 NDA: 090299

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

Suppliers and Packaging for NDA: 090299

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MELPHALAN HYDROCHLORIDE
melphalan hydrochloride
INJECTABLE;INJECTION 090299 ANDA GeneraMedix Inc. 10139-321 10139-321-01 1 KIT in 1 CARTON (10139-321-01) * 10 mL in 1 VIAL, SINGLE-DOSE (10139-319-10) * 10 mL in 1 VIAL (10139-320-10)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:Oct 27, 2009TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Covington
McKinsey
UBS
QuintilesIMS
Boehringer Ingelheim
Argus Health
Healthtrust
Fuji
Daiichi Sankyo
Harvard Business School

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