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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
US Department of Justice
Federal Trade Commission

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076657

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NDA 076657 describes IFOSFAMIDE, which is a drug marketed by Fresenius Kabi Usa, Mylan Labs Ltd, Teva Pharms Usa, and West-ward Pharms Int, and is included in six NDAs. It is available from six suppliers. Additional details are available on the IFOSFAMIDE profile page.

The generic ingredient in IFOSFAMIDE is ifosfamide; mesna. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ifosfamide; mesna profile page.
Summary for 076657
Applicant:Teva Pharms Usa
Formulation / Manufacturing:see details
Pharmacology for NDA: 076657
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 076657
Suppliers and Packaging for NDA: 076657
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IFOSFAMIDE ifosfamide INJECTABLE;INJECTION 076657 ANDA Teva Parenteral Medicines, Inc. 0703-3427 0703-3427-11 1 VIAL, SINGLE-USE in 1 CARTON (0703-3427-11) > 20 mL in 1 VIAL, SINGLE-USE
IFOSFAMIDE ifosfamide INJECTABLE;INJECTION 076657 ANDA Teva Parenteral Medicines, Inc. 0703-3429 0703-3429-11 1 VIAL, SINGLE-USE in 1 CARTON (0703-3429-11) > 60 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/20ML (50MG/ML)
Approval Date:Apr 4, 2007TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3GM/60ML (50MG/ML)
Approval Date:Apr 4, 2007TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo

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