اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
COLISTIMETHATE SODIUM از شرکت XELLIA PHARMS APS
Abbreviated New Drug Application (ANDA): 205356
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 |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205356Orig1s000ltr.pdf |
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 | 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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