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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 064216

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NDA 064216 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 064216

Tradename:	COLISTIMETHATE SODIUM
Applicant:	Adrastea Pharma
Ingredient:	colistimethate sodium
Patents:	0

Pharmacology for NDA: 064216

Suppliers and Packaging for NDA: 064216

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLISTIMETHATE SODIUM	colistimethate sodium	INJECTABLE;INJECTION	064216	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-0615	39822-0615-2	12 CARTON in 1 CARTON (39822-0615-2) / 1 VIAL in 1 CARTON (39822-0615-1) / 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:	Feb 26, 1999	TE:	AP	RLD:	No

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