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Last Updated: April 5, 2025

Details for New Drug Application (NDA): 218871

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NDA 218871 describes MESNA, which is a drug marketed by Fresenius Kabi Usa, Gland, Hikma, Mylan Institutional, Rising, Sagent Pharms Inc, Teva Pharms Usa, and Riconpharma Llc, and is included in eight NDAs. It is available from five 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. Seven suppliers are listed for this compound. Additional details are available on the mesna profile page.

Summary for 218871

Tradename:	MESNA
Applicant:	Riconpharma Llc
Ingredient:	mesna
Patents:	0

Pharmacology for NDA: 218871

Medical Subject Heading (MeSH) Categories for 218871

Protective Agents

Suppliers and Packaging for NDA: 218871

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MESNA	mesna	TABLET;ORAL	218871	ANDA	Ingenus Pharmaceuticals, LLC	50742-354	50742-354-01	1 BLISTER PACK in 1 CARTON (50742-354-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Jan 13, 2025	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Jul 13, 2025
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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