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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 075811

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NDA 075811 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 075811

Tradename:	MESNA
Applicant:	Fresenius Kabi Usa
Ingredient:	mesna
Patents:	0

Pharmacology for NDA: 075811

Medical Subject Heading (MeSH) Categories for 075811

Protective Agents

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 (63323-733-01)
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:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	100MG/ML
Approval Date:	Apr 26, 2001	TE:	AP	RLD:	No

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