Zosyn

NDA 50684, held by Wyeth Pharms. Piperacillin Sodium; Tazobactam Sodium.

As of Nov 13, 2026, NDA 50684 (Zosyn), held by Wyeth Pharms, was first approved by FDA on Oct 22, 1993, with 62 approved supplements and 0 published complete response letters.

First approved: Oct 22, 1993
Review: Standard
Supplements approved: 62
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 63 submissions below

Date	Submission	Status	Documents
May 26, 2020	Supplement 96Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 26, 2006	Supplement 46Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 28, 2003	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 8, 1996	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Oct 22, 1993	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
ZosynEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Piperacillin Sodium; Tazobactam Sodium	DiscontinuedReference drug
ZosynEQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Piperacillin Sodium; Tazobactam Sodium	DiscontinuedReference drug
ZosynEQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Piperacillin Sodium; Tazobactam Sodium	DiscontinuedReference drug
ZosynEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Piperacillin Sodium; Tazobactam Sodium	DiscontinuedReference drug

All 63 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 3, 2024	Supplement 105Labeling · Standard review	Approved	Label Letter
May 1, 2024	Supplement 104Labeling · Standard review	Approved	Label Letter
Dec 16, 2022	Supplement 101Labeling · Standard review	Approved	Letter Label
Apr 8, 2022	Supplement 100Labeling · Standard review	Approved	Letter Label
Jul 29, 2021	Supplement 98Labeling · Standard review	Approved	Letter Label
May 26, 2020	Supplement 96Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 13, 2020	Supplement 95Labeling · Standard review	Approved	Label Letter
May 10, 2019	Supplement 94Labeling · Standard review	Approved	Letter Label
May 5, 2017	Supplement 88Labeling · Standard review	Approved	Letter Label
May 5, 2017	Supplement 89Labeling · Standard review	Approved	Letter Label
May 5, 2017	Supplement 90Labeling · Standard review	Approved	Letter Label
Jun 10, 2016	Supplement 84Labeling · Standard review	Approved	Letter Label
Jun 10, 2016	Supplement 86Labeling · Standard review	Approved	Letter Label
May 16, 2016	Supplement 85Manufacturing · Standard review	Approved	None posted
Dec 18, 2015	Supplement 83Labeling · Standard review	Approved	Label Letter
Aug 5, 2014	Supplement 82Manufacturing · Standard review	Approved	None posted
Feb 25, 2014	Supplement 81Manufacturing · Standard review	Approved	None posted
Sep 6, 2013	Supplement 63Labeling · Standard review	Approved	Letter Label
Sep 6, 2013	Supplement 74Labeling · Standard review	Approved	Letter Label
Sep 6, 2013	Supplement 80Labeling · Standard review	Approved	Letter Label
Aug 20, 2013	Supplement 79Manufacturing · Standard review	Approved	None posted
Mar 27, 2013	Supplement 78Manufacturing · Standard review	Approved	None posted
May 11, 2012	Supplement 55Labeling · Standard review	Approved	Label
May 11, 2012	Supplement 61Labeling · Standard review	Approved	Label Letter
Sep 28, 2011	Supplement 71Labeling · Standard review	Approved	Letter Label
Apr 17, 2008	Supplement 51Labeling · Standard review	Approved	Label Letter
Apr 17, 2008	Supplement 52Labeling · Standard review	Approved	Label Letter
Jan 11, 2008	Supplement 53Manufacturing	Approved	None posted
Jul 26, 2006	Supplement 46Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 30, 2005	Supplement 45Manufacturing · Standard review	Approved	Review Letter Label
Jun 27, 2005	Supplement 44Labeling · Standard review	Approved	Letter
Mar 15, 2005	Supplement 39Labeling · Standard review	Approved	Letter
Jan 30, 2004	Supplement 38Labeling · Standard review	Approved	Letter
May 1, 2003	Supplement 35Labeling · Standard review	Approved	Letter Label
Apr 28, 2003	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 4, 2002	Supplement 32Manufacturing · Standard review	Approved	None posted
Oct 10, 2002	Supplement 31Manufacturing · Standard review	Approved	None posted
Mar 27, 2002	Supplement 15Labeling · Standard review	Approved	Letter
Mar 15, 2002	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 15, 2002	Supplement 29Manufacturing · Standard review	Approved	None posted
Mar 14, 2002	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 26, 2002	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 19, 2001	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 20, 2001	Supplement 23Manufacturing · Standard review	Approved	None posted
Feb 1, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Nov 22, 2000	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 21, 2000	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 1, 2000	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 1, 2000	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 1, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 11, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 13, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 31, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 16, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 13, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 18, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
May 8, 1996	Supplement 1Efficacy (new indication or use) · Standard review	Approved	None posted
Jul 10, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 12, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 24, 1994	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 13, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Jul 13, 1994	Supplement 2Labeling · Standard review	Approved	None posted
Oct 22, 1993	Original applicationNew molecular entity, new combination · Standard review	Approved	None posted

Show all 63

Identifiers

Application: NDA 50684
Drugs@FDA: Overview at FDA
Company: Wyeth Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters

Date

Submission

Status

Documents

May 26, 2020

Supplement 96Efficacy (new indication or use) · Standard review

Approved