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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/24/1998 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50750.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/16/2022 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050750s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050750Orig1s049ltr.pdf | |
| 03/23/2022 | SUPPL-48 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050750Orig1s048edtlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050750Orig1s048Correctedltr.pdf | |
| 04/08/2022 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050684s100,050750s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050684Orig1s100, 050750Orig1s047ltr.pdf | |
| 07/29/2021 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050684s098,050750s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050684Orig1s098; 050750Orig1s045ltr.pdf | |
| 05/26/2020 | SUPPL-43 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050684s096,050750s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050684Orig1s096,050750Orig1s043ltr.pdf | |
| 04/13/2020 | SUPPL-42 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050684Orig1s095,%20050750Orig1s042ltr.pdf |
| 05/10/2019 | SUPPL-41 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050684Orig1s094 050750Orig1s041ltr.pdf |
| 05/05/2017 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050684Orig1s088,s089,s090,050750Orig1s037,s038,s039ltr.pdf |
| 05/05/2017 | SUPPL-38 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050684Orig1s088,s089,s090,050750Orig1s037,s038,s039ltr.pdf | |
| 05/05/2017 | SUPPL-37 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050684Orig1s088,s089,s090,050750Orig1s037,s038,s039ltr.pdf | |
| 06/10/2016 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,050750Orig1s034,s035ltr.pdf | |
| 06/10/2016 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050684Orig1s084,s086,050750Orig1s034,s035ltr.pdf | |
| 12/18/2015 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050684s083,050750s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050684Orig1s083; 050750Orig1s033ltr.pdf | |
| 06/24/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/2013 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf | |
| 06/18/2013 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/2013 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.pdf | |
| 09/28/2011 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050684s071,050750s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050684s071,050750s024ltr.pdf | |
| 09/06/2013 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050684Orig1s063,s074,s080,050750Orig1s021,s026,s030ltr.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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050684s061,050750s016ltr.pdf | |
| 04/17/2008 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050750s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050750s015ltr.pdf | |
| 07/26/2006 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050750s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050750s014LTR.pdf | |
| 09/30/2005 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050684s045,050750s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s045,050750s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050684_S045_050750_s012_ZosynTOC.cfm | |
| 06/27/2005 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050684s044,050750s011ltr.pdf |
| 03/15/2005 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50684s039,50750s009ltr.pdf |
| 05/06/2003 | SUPPL-8 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050750s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50750se2-008ltr.pdf | |
| 05/06/2003 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050750s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50750slr007ltr.pdf | |
| 03/14/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/2002 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50750s003ltr.pdf |
| 07/13/1998 | 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 |
|---|---|---|---|---|---|
| 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 |