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Details for New Drug Application (NDA): 076078

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NDA 076078 describes IFOSFAMIDE, which is a drug marketed by West-ward Pharms Int, Teva Pharms Usa, Fresenius Kabi Usa, and Mylan Labs Ltd, and is included in six NDAs. It is available from five 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 NDA: 076078

Tradename:
IFOSFAMIDE
Applicant:
Fresenius Kabi Usa
Ingredient:
ifosfamide
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 076078

Mechanism of ActionAlkylating Activity

Suppliers and Packaging for NDA: 076078

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IFOSFAMIDE
ifosfamide
INJECTABLE;INJECTION 076078 ANDA APP Pharmaceuticals, LLC 63323-142 63323-142-10 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (63323-142-10)
IFOSFAMIDE
ifosfamide
INJECTABLE;INJECTION 076078 ANDA APP Pharmaceuticals, LLC 63323-142 63323-142-12 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (63323-142-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/VIAL
Approval Date:May 28, 2002TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3GM/VIAL
Approval Date:May 28, 2002TE:APRLD:Yes


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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