An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065364
Company: FRESENIUS KABI USA

Products on ANDA 065364

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 065364

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2008	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
03/19/2021	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/06/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065364

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	ENDO OPERATIONS

Top