Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050750
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOSYN IN PLASTIC CONTAINER | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 40MG BASE/ML;EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| ZOSYN IN PLASTIC CONTAINER | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 60MG BASE/ML;EQ 7.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| ZOSYN IN PLASTIC CONTAINER | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/100ML;EQ 500MG BASE/100ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/03/2024 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050750s053lbl.pdf | |
| 11/19/2024 | SUPPL-54 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050750Orig1s054lbl.pdf | |
| 05/01/2024 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050750s051lbl.pdf | |
| 12/16/2022 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050750s049lbl.pdf | |
| 04/08/2022 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050684s100,050750s047lbl.pdf | |
| 03/23/2022 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050750Orig1s048edtlbl.pdf | |
| 07/29/2021 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050684s098,050750s045lbl.pdf | |
| 05/26/2020 | SUPPL-43 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050684s096,050750s043lbl.pdf | |
| 05/05/2017 | SUPPL-39 | 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/2017/050684s88s89s90_050750s37s38s39lbl.pdf |
| 05/05/2017 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf | |
| 05/05/2017 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf | |
| 05/05/2017 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf | |
| 05/05/2017 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf | |
| 06/10/2016 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf | |
| 06/10/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf | |
| 12/18/2015 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050684s083,050750s033lbl.pdf | |
| 09/06/2013 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf | |
| 09/06/2013 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf | |
| 09/06/2013 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf | |
| 05/11/2012 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf | |
| 05/11/2012 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf | |
| 09/28/2011 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050684s071,050750s024lbl.pdf | |
| 04/17/2008 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050750s015lbl.pdf | |
| 07/26/2006 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050750s014lbl.pdf | |
| 09/30/2005 | SUPPL-12 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050684s045,050750s012lbl.pdf | |
| 05/06/2003 | SUPPL-8 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050750s008lbl.pdf | |
| 05/06/2003 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050750s007lbl.pdf |