Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050108
Company: PAR STERILE PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLY-MYCIN M COLISTIMETHATE SODIUM EQ 150MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/04/1970 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/14/2017 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050108s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050108Orig1s033ltr.pdf
03/07/2013 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050108s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050108Orig1s030ltr.pdf
05/13/2009 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050108s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050108s026ltr.pdf
01/12/2006 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050108s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050108s024ltr.pdf
12/20/2002 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50108slr023ltr.pdf
09/28/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1999 SUPPL-21 Labeling

Label is not available on this site.

04/28/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/23/1981 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/18/1980 SUPPL-18 Labeling

Label is not available on this site.

01/18/1980 SUPPL-17 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/31/1979 SUPPL-16 Labeling

Label is not available on this site.

12/08/1978 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1976 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1975 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1973 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/05/1972 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1971 SUPPL-8 Labeling

Label is not available on this site.

12/19/1970 SUPPL-7 Labeling

Label is not available on this site.

12/22/1970 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1970 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1985 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/1983 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/14/1983 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/07/1982 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/14/2017 SUPPL-33 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050108s033lbl.pdf
03/07/2013 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050108s030lbl.pdf
05/13/2009 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050108s026lbl.pdf
01/12/2006 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050108s024lbl.pdf

COLY-MYCIN M

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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