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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076619

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NDA 076619 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 four 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 076619
Tradename:IFOSFAMIDE
Applicant:West-ward Pharms Int
Ingredient:ifosfamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076619
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 076619
Suppliers and Packaging for NDA: 076619
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IFOSFAMIDE ifosfamide INJECTABLE;INJECTION 076619 ANDA West-Ward Pharmaceuticals Corp 0143-9530 N 0143-9530-01
IFOSFAMIDE ifosfamide INJECTABLE;INJECTION 076619 ANDA West-Ward Pharmaceuticals Corp 0143-9531 N 0143-9531-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/20ML (50MG/ML)
Approval Date:Jun 29, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3GM/60ML (50MG/ML)
Approval Date:Jun 29, 2011TE:APRLD:No

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