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BioPharmaceutical Business Intelligence

  • Identify first generic entrants
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Serving leading biopharmaceutical companies globally:

Dow
Moodys
Cipla
Harvard Business School
Queensland Health
Novartis
AstraZeneca
Baxter
Chubb
Daiichi Sankyo

Generated: November 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076619

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NDA 076619 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 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 076619

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

Pharmacology for NDA: 076619

Mechanism of ActionAlkylating Activity

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 0143-9531 0143-9531-01 1 VIAL in 1 BOX (0143-9531-01) > 20 mL in 1 VIAL

Summary for product number 001

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

Summary 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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Serving leading biopharmaceutical companies globally:

Chubb
Accenture
AstraZeneca
Dow
Chinese Patent Office
McKinsey
Julphar
Express Scripts
Mallinckrodt
Baxter

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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