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Drugs@FDA: FDA-Approved Drugs

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

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 EMCURE PHARMS LTD
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 PHARMS
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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