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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205356

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NDA 205356 describes COLISTIMETHATE SODIUM, which is a drug marketed by Avet Lifesciences, Fresenius Kabi Usa, Nexus, Pharmobedient, Sagent Pharms Inc, and Xellia Pharms Aps, and is included in six NDAs. It is available from three 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. Four suppliers are listed for this compound. Additional details are available on the colistimethate sodium profile page.

Summary for 205356

Tradename:	COLISTIMETHATE SODIUM
Applicant:	Xellia Pharms Aps
Ingredient:	colistimethate sodium
Patents:	0

Pharmacology for NDA: 205356

Suppliers and Packaging for NDA: 205356

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	205356	ANDA	Xellia Pharmaceuticals USA LLC	70594-023	70594-023-09	1 VIAL in 1 CARTON (70594-023-09) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	205356	ANDA	Xellia Pharmaceuticals USA LLC	70594-023	70594-023-01	1 VIAL, GLASS in 1 VIAL (70594-023-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 150MG BASE/VIAL
Approval Date:	May 29, 2015	TE:	AP	RLD:	No

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