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
CEFAZOLIN AND DEXTROSE از شرکت B BRAUN
New Drug Application (NDA): 050779
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFAZOLIN AND DEXTROSE | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| CEFAZOLIN AND DEXTROSE | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
None |
Yes | Yes |
| CEFAZOLIN AND DEXTROSE | CEFAZOLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/27/2000 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50779lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/23/2020 | SUPPL-27 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050779s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050779Orig1s027ltr.pdf |
||
| 10/08/2015 | SUPPL-25 | 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/2015/050779s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050779Orig1s025ltr.pdf |
|
| 09/18/2014 | SUPPL-23 | Efficacy-Pediatric |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050779Orig1s023ltr.pdf |
|
| 08/21/2013 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/2012 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/2012 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050779s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050779s019ltr.pdf |
||
| 01/13/2012 | SUPPL-18 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050779s018lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050779s018ltr.pdf |
||
| 09/10/2007 | SUPPL-13 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050779s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050779s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/050779s013ltr.pdf |
||
| 10/31/2008 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050779s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050779s011ltr.pdf |
||
| 05/06/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050779s006ltr.pdf |
|
| 06/29/2004 | SUPPL-5 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50779slr005_cefazolin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50779slr005ltr.pdf |
||
| 06/01/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/23/2020 | SUPPL-27 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050779s027lbl.pdf | |
| 10/08/2015 | SUPPL-25 |
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/2015/050779s025lbl.pdf |
| 04/23/2012 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050779s019lbl.pdf | |
| 01/13/2012 | SUPPL-18 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050779s018lb.pdf | |
| 10/31/2008 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050779s011lbl.pdf | |
| 09/10/2007 | SUPPL-13 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050779s013lbl.pdf | |
| 06/29/2004 | SUPPL-5 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50779slr005_cefazolin_lbl.pdf | |
| 07/27/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50779lbl.pdf |
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