FDA.reportPublic FDA data

Application 050684

Type
NDA
Sponsor
WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOSYNPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALYesYes
002ZOSYNPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALYesYes
003ZOSYNPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALYesYes
004ZOSYNPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0206-8852Zosynpiperacillin sodium and tazobactam sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0206-8852Zosynpiperacillin sodium and tazobactam sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0206-8852Zosynpiperacillin sodium and tazobactam sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0206-8854Zosynpiperacillin sodium and tazobactam sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0206-8854Zosynpiperacillin sodium and tazobactam sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0206-8854Zosynpiperacillin sodium and tazobactam sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0206-8855Zosynpiperacillin sodium and tazobactam sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0206-8855Zosynpiperacillin sodium and tazobactam sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0206-8855Zosynpiperacillin sodium and tazobactam sodiumWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0206-8859ZosynPIPERACILLIN SODIUM and TAZOBACTAM SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0206-8859ZosynPIPERACILLIN SODIUM and TAZOBACTAM SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0206-8859ZosynPIPERACILLIN SODIUM and TAZOBACTAM SODIUMWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80515SUPPL 2024-12-05
80492SUPPL 2024-12-04
78385SUPPL 2024-05-03
78352SUPPL 2024-05-02
72932SUPPL2022-12-20
72921SUPPL2022-12-19
70749SUPPL2022-04-11
70742SUPPL2022-04-11
68264SUPPL2021-08-02
68238SUPPL2021-08-02
63326SUPPL2020-05-28
63302SUPPL2020-05-27
62564SUPPL2020-04-14
62556SUPPL2020-04-14
58700SUPPL2019-05-14
58676SUPPL2019-05-14
48309SUPPL2017-05-09
48308SUPPL2017-05-09
48307SUPPL2017-05-09
48272SUPPL2017-05-08
48271SUPPL2017-05-08
48270SUPPL2017-05-08
39111SUPPL2016-06-13
39110SUPPL2016-06-13
30274SUPPL2016-06-13
8002SUPPL2016-06-13
18018SUPPL2015-12-29
8001SUPPL2015-12-22
30273SUPPL2013-09-11
30272SUPPL2013-09-11
8000SUPPL2013-09-11
39109SUPPL2013-09-09
18017SUPPL2013-09-09
18016SUPPL2013-09-09
30271SUPPL2012-05-15
18015SUPPL2012-05-15
18014SUPPL2012-05-15
7999SUPPL2011-10-03
39108SUPPL2011-09-30
39107SUPPL2008-06-05
18013SUPPL2008-06-05
30270SUPPL2008-04-22
7998SUPPL2008-04-22
22183SUPPL2007-06-11
7997SUPPL2006-08-04
18012SUPPL2006-07-27
30269SUPPL2005-10-20
18011SUPPL2005-10-10
7996SUPPL2005-06-29
7995SUPPL2005-03-18
30268SUPPL2004-02-03
7994SUPPL2003-05-30
7993SUPPL2003-05-29
39106SUPPL2003-05-06
39105SUPPL2003-04-30
7992SUPPL2002-03-27