Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207131
Company: BAXTER HLTHCARE CORP
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 |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207131s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207131Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207131Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207131Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/01/2024 | SUPPL-9 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207131s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207131Orig1s009ltr.pdf | |
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)
Letter (PDF) |
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-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
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 |
---|---|---|---|---|---|
02/01/2024 | SUPPL-9 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207131s009lbl.pdf | |
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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207131s003lbl.pdf | |
10/11/2016 | SUPPL-3 | Labeling-Container/Carton Labels | 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 |