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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
US Department of Justice

Generated: February 22, 2018

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
Applicant:Sun Pharma Global
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 E 62756-581-42
AMIFOSTINE amifostine INJECTABLE;INJECTION 077126 ANDA Sun Pharmaceutical Industries Limited 62756-581 E 62756-581-40

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health
Fish and Richardson

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