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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 206992

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NDA 206992 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 206992

Tradename:	MESNA
Applicant:	Gland
Ingredient:	mesna
Patents:	0

Pharmacology for NDA: 206992

Medical Subject Heading (MeSH) Categories for 206992

Protective Agents

Suppliers and Packaging for NDA: 206992

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MESNA	mesna	INJECTABLE;INTRAVENOUS	206992	ANDA	Gland Pharma Limited	68083-161	68083-161-01	1 VIAL, MULTI-DOSE in 1 CARTON (68083-161-01) / 10 mL in 1 VIAL, MULTI-DOSE
MESNA	mesna	INJECTABLE;INTRAVENOUS	206992	ANDA	Gland Pharma Limited	68083-161	68083-161-10	10 VIAL, MULTI-DOSE in 1 CARTON (68083-161-10) / 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:	Dec 18, 2017	TE:	AP	RLD:	No

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