Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064216
Company: X GEN 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
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.

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 064216 X GEN PHARMS
COLISTIMETHATE SODIUM COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205356 XELLIA PHARMS APS
COLY-MYCIN M COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050108 PAR STERILE PRODUCTS

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