Application 050750

Type: NDA
Sponsor: WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOSYN IN PLASTIC CONTAINER	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML;EQ 5MG BASE/ML	Yes	Yes
002	ZOSYN IN PLASTIC CONTAINER	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	INJECTABLE;INJECTION	EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	Yes	Yes
003	ZOSYN IN PLASTIC CONTAINER	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	INJECTABLE;INJECTION	EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0206-8860	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8860	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8860	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8860	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8860	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8860	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8860	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8860	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8860	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8860	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8861	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8861	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8861	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8861	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8861	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8861	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8861	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8861	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8861	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8861	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8862	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8862	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8862	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8862	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8862	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8862	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8862	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8862	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8862	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0206-8862	Zosyn	TAZOBACTAM SODIUM and PIPERACILLIN SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80517	SUPPL	2024-12-05
80494	SUPPL	2024-12-04
80260	SUPPL	2024-11-21
80256	SUPPL	2024-11-21
78377	SUPPL	2024-05-03
78353	SUPPL	2024-05-02
78336	SUPPL	2024-05-02
72931	SUPPL	2022-12-20
72922	SUPPL	2022-12-19
70750	SUPPL	2022-04-11
70743	SUPPL	2022-04-11
70696	SUPPL	2022-04-05
70593	SUPPL	2022-03-24
68265	SUPPL	2021-08-02
68239	SUPPL	2021-08-02
63327	SUPPL	2020-05-28
63303	SUPPL	2020-05-27
62565	SUPPL	2020-04-14
58678	SUPPL	2019-05-14
48312	SUPPL	2017-05-09
48311	SUPPL	2017-05-09
48310	SUPPL	2017-05-09
48275	SUPPL	2017-05-08
48274	SUPPL	2017-05-08
48273	SUPPL	2017-05-08
39252	SUPPL	2016-06-13
30445	SUPPL	2016-06-13
18174	SUPPL	2016-06-13
8182	SUPPL	2016-06-13
39251	SUPPL	2015-12-29
8181	SUPPL	2015-12-22
30444	SUPPL	2013-09-11
8180	SUPPL	2013-09-11
8178	SUPPL	2013-09-11
39250	SUPPL	2013-09-09
39248	SUPPL	2013-09-09
18173	SUPPL	2013-09-09
39247	SUPPL	2012-05-15
18172	SUPPL	2012-05-15
8177	SUPPL	2012-05-15
8179	SUPPL	2011-10-03
39249	SUPPL	2011-09-30
39246	SUPPL	2008-06-05
30443	SUPPL	2008-04-22
22218	SUPPL	2007-06-11
30442	SUPPL	2006-08-04
39245	SUPPL	2006-07-27
30441	SUPPL	2005-10-20
18171	SUPPL	2005-10-10
8176	SUPPL	2005-06-29
8175	SUPPL	2005-03-18
30440	SUPPL	2003-05-30
30439	SUPPL	2003-05-30
39244	SUPPL	2003-05-13
18170	SUPPL	2003-05-13
8174	SUPPL	2002-03-27
22217	ORIG	1998-02-24

Application 050750

Related Records#

Application Products#

NDC Listings For This Application#

Documents#