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Serving leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
Fish and Richardson
Johnson and Johnson

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090913

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NDA 090913 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 090913
Applicant:Sagent Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 090913
Medical Subject Heading (MeSH) Categories for 090913
Suppliers and Packaging for NDA: 090913
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESNA mesna INJECTABLE;INTRAVENOUS 090913 ANDA Sagent Pharmaceuticals 25021-201 25021-201-69 10 VIAL in 1 CARTON (25021-201-69) > 10 mL in 1 VIAL
MESNA mesna INJECTABLE;INTRAVENOUS 090913 ANDA Sagent Pharmaceuticals 25021-201 25021-201-68 1 VIAL in 1 CARTON (25021-201-68) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength100MG/ML
Approval Date:Apr 13, 2010TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson

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