Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050684
Company: WYETH PHARMS
Company: WYETH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ZOSYN | PIPERACILLIN SODIUM; TAZOBACTAM SODIUM | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/22/1993 | ORIG-1 | Approval | Type 1 - New Molecular Entity and Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/16/2022 | SUPPL-101 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050684s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050684Orig1s101ltr.pdf | |
| 04/08/2022 | SUPPL-100 | 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-98 | 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-96 | 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-95 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050684s095lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050684Orig1s095, 050750Orig1s042ltr.pdf | |
| 05/10/2019 | SUPPL-94 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050684s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050684Orig1s094 050750Orig1s041ltr.pdf | |
| 05/05/2017 | SUPPL-90 | 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-89 | 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-88 | 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-86 | 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 | |
| 05/16/2016 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2016 | SUPPL-84 | 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-83 | 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 | |
| 08/05/2014 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/2014 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/2013 | SUPPL-80 | 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 | |
| 08/20/2013 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/2013 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/2013 | SUPPL-74 | 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-71 | 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-63 | 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-61 | 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 | |
| 05/11/2012 | SUPPL-55 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf | |
| 01/11/2008 | SUPPL-53 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/17/2008 | SUPPL-52 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050684s051s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050684s051, s052ltr.pdf | |
| 04/17/2008 | SUPPL-51 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050684s051s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050684s051, s052ltr.pdf | |
| 07/26/2006 | SUPPL-46 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050684s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050684s046LTR.pdf | |
| 09/30/2005 | SUPPL-45 | 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-44 | 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-39 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50684s039,50750s009ltr.pdf |
| 01/30/2004 | SUPPL-38 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50684slr038ltr.pdf |
| 05/01/2003 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050684s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50684slr035ltr.pdf | |
| 04/28/2003 | SUPPL-33 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050684s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50684se2-033ltr.pdf | |
| 12/04/2002 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/10/2002 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/2002 | SUPPL-29 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/14/2002 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/2002 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/19/2001 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/2001 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/01/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/01/2000 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/01/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/01/2000 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/27/2002 | SUPPL-15 | 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-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1997 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1997 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/18/1996 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/13/1996 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/10/1995 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/1994 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/13/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/24/1994 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/13/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/08/1996 | SUPPL-1 | Efficacy-New Indication |
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-101 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050684s101lbl.pdf | |
| 04/08/2022 | SUPPL-100 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/050684s100,050750s047lbl.pdf | |
| 07/29/2021 | SUPPL-98 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050684s098,050750s045lbl.pdf | |
| 05/26/2020 | SUPPL-96 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050684s096,050750s043lbl.pdf | |
| 04/13/2020 | SUPPL-95 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050684s095lbl.pdf | |
| 05/10/2019 | SUPPL-94 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050684s094lbl.pdf | |
| 05/05/2017 | SUPPL-90 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf | |
| 05/05/2017 | SUPPL-89 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf | |
| 05/05/2017 | SUPPL-89 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf | |
| 05/05/2017 | SUPPL-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf | |
| 05/05/2017 | SUPPL-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050684s88s89s90_050750s37s38s39lbl.pdf | |
| 06/10/2016 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf | |
| 06/10/2016 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050684s084s086,050750s034s035lbl.pdf | |
| 12/18/2015 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050684s083,050750s033lbl.pdf | |
| 09/06/2013 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf | |
| 09/06/2013 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf | |
| 09/06/2013 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050684s063s074s080,050750s021s026s030lbl.pdf | |
| 05/11/2012 | SUPPL-61 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf | |
| 05/11/2012 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050684s055s061_050750s016s020lbl.pdf | |
| 09/28/2011 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050684s071,050750s024lbl.pdf | |
| 04/17/2008 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050684s051s052lbl.pdf | |
| 04/17/2008 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050684s051s052lbl.pdf | |
| 07/26/2006 | SUPPL-46 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050684s046lbl.pdf | |
| 09/30/2005 | SUPPL-45 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050684s045,050750s012lbl.pdf | |
| 05/01/2003 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050684s035lbl.pdf | |
| 04/28/2003 | SUPPL-33 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050684s033lbl.pdf |