Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050108
Company: PAR STERILE PRODUCTS
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 | 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 |