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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 065364

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NDA 065364 describes COLISTIMETHATE SODIUM, which is a drug marketed by Adrastea Pharma, Avet Lifesciences, Fresenius Kabi Usa, Nexus, Sagent Pharms Inc, and Xellia Pharms Aps, and is included in six NDAs. It is available from four suppliers. Additional details are available on the COLISTIMETHATE SODIUM profile page.

The generic ingredient in COLISTIMETHATE SODIUM is colistimethate sodium. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.

Summary for 065364

Tradename:	COLISTIMETHATE SODIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	colistimethate sodium
Patents:	0

Pharmacology for NDA: 065364

Suppliers and Packaging for NDA: 065364

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	065364	ANDA	Fresenius Kabi USA, LLC	63323-393	63323-393-06	1 VIAL in 1 BOX (63323-393-06) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 150MG BASE/VIAL
Approval Date:	Apr 17, 2008	TE:	AP	RLD:	No

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