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 IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE CORP
New Drug Application (NDA): 207131
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFAZOLIN IN PLASTIC CONTAINER | CEFAZOLIN SODIUM | EQ 2GM BASE/100ML (EQ 20MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| CEFAZOLIN IN PLASTIC CONTAINER | CEFAZOLIN SODIUM | EQ 1GM BASE/50ML (EQ 20MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 08/07/2015 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207131s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/20/2021 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207131s008lbl.pdf |
||
| 02/01/2021 | SUPPL-6 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207131s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207131Orig1s006ltr.pdf |
||
| 10/11/2016 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207131s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207131Orig1s003ltr.pdf |
||
| 08/01/2016 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/2016 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/20/2021 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207131s008lbl.pdf | |
| 02/01/2021 | SUPPL-6 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207131s006lbl.pdf | |
| 10/11/2016 | SUPPL-3 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207131s003lbl.pdf | |
| 10/11/2016 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207131s003lbl.pdf | |
| 08/07/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207131s000lbl.pdf |
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