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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 090913


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NDA 090913 describes MESNA, which is a drug marketed by Fresenius Kabi Usa, Gland, Hikma, Mylan Institutional, Rising, Sagent Pharms Inc, and Teva Pharms Usa, and is included in seven 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. Six suppliers are listed for this compound. Additional details are available on the mesna profile page.
Summary for 090913
Tradename:MESNA
Applicant:Sagent Pharms Inc
Ingredient:mesna
Patents:0
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 25021-201-10 1 VIAL in 1 CARTON (25021-201-10) / 10 mL in 1 VIAL
MESNA mesna INJECTABLE;INTRAVENOUS 090913 ANDA Sagent Pharmaceuticals 25021-201 25021-201-11 10 VIAL in 1 CARTON (25021-201-11) / 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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