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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 202359

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NDA 202359 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 202359

Tradename:	COLISTIMETHATE SODIUM
Applicant:	Avet Lifesciences
Ingredient:	colistimethate sodium
Patents:	0

Pharmacology for NDA: 202359

Suppliers and Packaging for NDA: 202359

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	202359	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-193	23155-193-31	1 VIAL, GLASS in 1 CARTON (23155-193-31) / 4 mL in 1 VIAL, GLASS
COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	202359	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-193	23155-193-41	12 VIAL, GLASS in 1 CARTON (23155-193-41) / 4 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 150MG BASE/VIAL
Approval Date:	Sep 28, 2012	TE:	AP	RLD:	No

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