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
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER از شرکت B BRAUN
New Drug Application (NDA): 050796
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
Yes | Yes |
| CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER | CEFTRIAXONE 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 |
|---|---|---|---|---|---|---|---|
| 04/20/2005 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050796lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/09/2021 | SUPPL-25 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050796s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050796Orig1s025ltr.pdf |
||
| 09/09/2020 | SUPPL-23 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050796s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050796Orig1s023ltr.pdf |
||
| 07/09/2015 | SUPPL-19 | 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/2015/050796Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050796Orig1s019ltr.pdf |
|
| 02/07/2014 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2013 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050796Orig1s017ltr.pdf |
||
| 03/11/2013 | SUPPL-14 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050796Origs014ltr.pdf |
||
| 06/25/2010 | SUPPL-12 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050796s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050796s012ltr.pdf |
||
| 01/13/2012 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050796Orig1s011lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050796s011ltr(2).pdf |
||
| 05/08/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050796s007,050796s008ltr.pdf |
|
| 05/08/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050796s007,050796s008ltr.pdf |
|
| 09/10/2007 | SUPPL-4 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050796s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050796s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/09/2021 | SUPPL-25 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050796s025lbl.pdf | |
| 09/09/2020 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050796s023lbl.pdf | |
| 07/09/2015 | SUPPL-19 |
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/2015/050796Orig1s019lbl.pdf |
| 04/10/2013 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s017lbl.pdf | |
| 03/11/2013 | SUPPL-14 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050796s014lbl.pdf | |
| 01/13/2012 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050796Orig1s011lbledt.pdf | |
| 06/25/2010 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050796s012lbl.pdf | |
| 09/10/2007 | SUPPL-4 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050796s004lbl.pdf | |
| 04/20/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050796lbl.pdf |
CEFTRIAXONE 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 |
|---|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065329 | ACS DOBFAR |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065204 | SANDOZ INC |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065180 | WOCKHARDT |
| CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050796 | 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 |
|---|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065329 | ACS DOBFAR |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065204 | SANDOZ INC |
| CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050796 | B BRAUN |
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