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
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER از شرکت B BRAUN
New Drug Application (NDA): 065214
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
Yes | Yes |
| CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER | CEFOXITIN SODIUM | EQ 2GM 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 |
|---|---|---|---|---|---|---|---|
| 03/10/2006 | 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 |
|---|---|---|---|---|---|
| 07/29/2019 | SUPPL-16 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/065214s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/065214Orig1s016ltr.pdf |
||
| 06/05/2013 | SUPPL-13 | Labeling-Package Insert |
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/2013/065214s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/065214Orig1s013ltr.pdf |
|
| 12/12/2012 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/2010 | SUPPL-8 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s008lbl.pdf |
||
| 01/07/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/04/2010 | SUPPL-2 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s002lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/29/2019 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/065214s016lbl.pdf | |
| 06/05/2013 | SUPPL-13 |
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/2013/065214s013lbl.pdf |
| 02/22/2010 | SUPPL-8 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s008lbl.pdf | |
| 02/04/2010 | SUPPL-2 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/065214s002lbl.pdf |
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFOXITIN | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065414 | ACS DOBFAR |
| CEFOXITIN | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065238 | HIKMA FARMACEUTICA |
| CEFOXITIN | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065051 | WEST-WARD PHARMS INT |
| CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 065214 | B BRAUN |
INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFOXITIN | CEFOXITIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065414 | ACS DOBFAR |
| CEFOXITIN | CEFOXITIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065238 | HIKMA FARMACEUTICA |
| CEFOXITIN | CEFOXITIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065051 | WEST-WARD PHARMS INT |
| CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER | CEFOXITIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 065214 | B BRAUN |
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