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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201689

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NDA 201689 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 201689

Formulation / Manufacturing:see details

Pharmacology for NDA: 201689

Mechanism of ActionAlkylating Activity

Suppliers and Packaging for NDA: 201689

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IFOSFAMIDE ifosfamide INJECTABLE;INJECTION 201689 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-4495 0069-4495-22 20 mL in 1 VIAL (0069-4495-22)
IFOSFAMIDE ifosfamide INJECTABLE;INJECTION 201689 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-4496 0069-4496-22 60 mL in 1 VIAL (0069-4496-22)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/20ML (50MG/ML)
Approval Date:Nov 26, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3GM/60ML (50MG/ML)
Approval Date:Nov 26, 2012TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Argus Health
Fish and Richardson

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