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 XGEN PHARMS
Abbreviated New Drug Application (ANDA): 064216
Company: XGEN 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 |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/64216ltr.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 | 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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