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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Merck
Chubb
US Department of Justice
Covington
Daiichi Sankyo
Chinese Patent Office
UBS
Fish and Richardson

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077126

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NDA 077126 describes AMIFOSTINE, which is a drug marketed by Mylan Labs Ltd and Sun Pharma Global and is included in two NDAs. It is available from one supplier. Additional details are available on the AMIFOSTINE profile page.

The generic ingredient in AMIFOSTINE is amifostine. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amifostine profile page.

Summary for 077126

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

Medical Subject Heading (MeSH) Categories for 077126

Suppliers and Packaging for NDA: 077126

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIFOSTINE amifostine INJECTABLE;INJECTION 077126 ANDA Sun Pharmaceutical Industries Limited 62756-581 62756-581-42 3 VIAL, SINGLE-USE in 1 CARTON (62756-581-42) > 10 mL in 1 VIAL, SINGLE-USE
AMIFOSTINE amifostine INJECTABLE;INJECTION 077126 ANDA Sun Pharmaceutical Industries Limited 62756-581 62756-581-40 1 VIAL, SINGLE-USE in 1 CARTON (62756-581-40) > 10 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Mar 14, 2008TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Julphar
Chinese Patent Office
Cipla
Healthtrust
Queensland Health
Deloitte
Colorcon
Novartis

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