Is there a generic for Colistimethate sodium?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Colistimethate sodium, referencing the brand COLY-MYCIN M. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Colistimethate sodium?

COLY-MYCIN M (NDA 050108, PH HEALTH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Colistimethate sodium are approved?

Colistimethate sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Colistimethate sodium

Colistimethate sodium is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:COLY-MYCIN M · NDA 050108

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
COLY-MYCIN MRLD	PH HEALTH	NDA 050108	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (6)

Product	Applicant	Application	TE	Approved
COLISTIMETHATE SODIUM	XELLIA PHARMS APS	ANDA 205356	AP	May 29, 2015
COLISTIMETHATE SODIUM	SAGENT PHARMS INC	ANDA 201365	AP	Feb 19, 2014
COLISTIMETHATE SODIUM	AVET LIFESCIENCES	ANDA 202359	AP	Sep 28, 2012
COLISTIMETHATE SODIUM	FRESENIUS KABI USA	ANDA 065364	AP	Apr 17, 2008
COLISTIMETHATE SODIUM	NEXUS	ANDA 065177	—	Mar 19, 2004
COLISTIMETHATE SODIUM	PHARMOBEDIENT	ANDA 064216	—	Feb 26, 1999

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Colistimethate sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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