Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050750
Company: WYETH PHARMS
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
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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English