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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064216
Company: XGEN PHARMS

Other Important Information from FDA

Products on ANDA 064216

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 064216

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/1999	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/64216ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/064216Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2018	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
06/27/2011	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/03/2006	SUPPL-8	Labeling		Label is not available on this site.
02/07/2006	SUPPL-6	Labeling		Label is not available on this site.
02/01/2002	SUPPL-4	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
07/13/2001	SUPPL-3	Labeling		Label is not available on this site.
05/01/2000	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 064216

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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