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Serving leading biopharmaceutical companies globally:

Healthtrust
Chinese Patent Office
Dow
Novartis
Accenture
US Army
Express Scripts
Cerilliant
Farmers Insurance
AstraZeneca

Generated: October 17, 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 Sun Pharma Global and Mylan Labs Ltd 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 NDA: 077126

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

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 62756-581-40 1 VIAL, SINGLE-USE in 1 CARTON (62756-581-40) > 10 mL in 1 VIAL, SINGLE-USE
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

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:

Fuji
Chubb
Johnson and Johnson
Covington
Novartis
McKesson
Mallinckrodt
Chinese Patent Office
Express Scripts
US Army

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