Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205356
Company: XELLIA PHARMS APS
Company: XELLIA PHARMS APS
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 |
---|---|---|---|---|---|---|---|
05/29/2015 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205356Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/12/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
06/12/2023 | SUPPL-1 | Labeling-Package Insert |
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 | 064216 | ADRASTEA PHARMA |
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 |
COLY-MYCIN M | COLISTIMETHATE SODIUM | EQ 150MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050108 | ENDO OPERATIONS |