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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065177
Company: NEXUS

Other Important Information from FDA

Products on ANDA 065177

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065177

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2021	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/17/2015	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/02/2005	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 065177

COLISTIMETHATE SODIUM

INJECTABLE;INJECTION; EQ 150MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202359	AVET LIFESCIENCES
COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065364	FRESENIUS KABI USA
COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065177	NEXUS
COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201365	SAGENT PHARMS INC
COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205356	XELLIA PHARMS APS
COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	064216	XGEN PHARMS
COLY-MYCIN M	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	050108	PAR STERILE PRODUCTS

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