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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 201365

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NDA 201365 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 201365

Tradename:	COLISTIMETHATE SODIUM
Applicant:	Sagent Pharms Inc
Ingredient:	colistimethate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 150MG BASE/VIAL
Approval Date:	Feb 19, 2014	TE:	AP	RLD:	No

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