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Serving leading biopharmaceutical companies globally:

Colorcon
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US Department of Justice
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075811

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NDA 075811 describes MESNA, which is a drug marketed by Fresenius Kabi Usa, Mylan Institutional, Mylan Labs Ltd, Sagent Pharms, 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 MESNA profile page.

The generic ingredient in MESNA is mesna. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the mesna profile page.
Summary for 075811
Tradename:MESNA
Applicant:Fresenius Kabi Usa
Ingredient:mesna
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075811
Medical Subject Heading (MeSH) Categories for 075811
Suppliers and Packaging for NDA: 075811
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESNA mesna INJECTABLE;INTRAVENOUS 075811 ANDA Fresenius Kabi USA, LLC 63323-733 63323-733-10 10 VIAL, MULTI-DOSE in 1 TRAY (63323-733-10) > 10 mL in 1 VIAL, MULTI-DOSE
MESNA mesna INJECTABLE;INTRAVENOUS 075811 ANDA Fresenius Kabi USA, LLC 63323-733 63323-733-11 1 VIAL, MULTI-DOSE in 1 BOX (63323-733-11) > 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength100MG/ML
Approval Date:Apr 26, 2001TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Citi
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Argus Health
Deloitte
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Healthtrust
Covington
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