← FDA DRUG APPROVALS

FDA NDA · NDA050684

ZOSYN

Sponsor: WYETH PHARMS

APPLICATION
NDA050684
TYPE
NDA
ORIGINAL APPROVAL
1993-10-22
LATEST ACTION
2024-12-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ZOSYN · ReferenceDiscontinued
PIPERACILLIN SODIUM EQ 36GM BASE/VIAL, TAZOBACTAM SODIUM EQ 4.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ZOSYN · ReferenceDiscontinued
PIPERACILLIN SODIUM EQ 3GM BASE/VIAL, TAZOBACTAM SODIUM EQ 375MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ZOSYN · ReferenceDiscontinued
PIPERACILLIN SODIUM EQ 4GM BASE/VIAL, TAZOBACTAM SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ZOSYN · ReferenceDiscontinued
PIPERACILLIN SODIUM EQ 2GM BASE/VIAL, TAZOBACTAM SODIUM EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2024-12-03Labeling · Supplement 105 · standard — Letter ↗AP
2024-05-01Labeling · Supplement 104 · standard — Letter ↗AP
2022-12-16Labeling · Supplement 101 · standard — Label ↗AP
2022-04-08Labeling · Supplement 100 · standard — Letter ↗AP
2021-07-29Labeling · Supplement 98 · standard — Letter ↗AP
2020-05-26Efficacy · Supplement 96 · standard — Label ↗AP
2020-04-13Labeling · Supplement 95 · standard — Label ↗AP
2019-05-10Labeling · Supplement 94 · standard — Letter ↗AP
2017-05-05Labeling · Supplement 89 · standard — Label ↗AP
2017-05-05Labeling · Supplement 88 · standard — Label ↗AP
2017-05-05Labeling · Supplement 90 · standard — Label ↗AP
2016-06-10Labeling · Supplement 86 · standard — Label ↗AP
2016-06-10Labeling · Supplement 84 · standard — Label ↗AP
2016-05-16Manufacturing (CMC) · Supplement 85 · standardAP
2015-12-18Labeling · Supplement 83 · standard — Letter ↗AP
2014-08-05Manufacturing (CMC) · Supplement 82 · standardAP
2014-02-25Manufacturing (CMC) · Supplement 81 · standardAP
2013-09-06Labeling · Supplement 63 · standard — Label ↗AP
2013-09-06Labeling · Supplement 74 · standard — Label ↗AP
2013-09-06Labeling · Supplement 80 · standard — Label ↗AP
2013-08-20Manufacturing (CMC) · Supplement 79 · standardAP
2013-03-27Manufacturing (CMC) · Supplement 78 · standardAP
2012-05-11Labeling · Supplement 55 · standard — Label ↗AP
2012-05-11Labeling · Supplement 61 · standard — Label ↗AP
2011-09-28Labeling · Supplement 71 · standard — Label ↗AP
2008-04-17Labeling · Supplement 52 · standard — Label ↗AP
2008-04-17Labeling · Supplement 51 · standard — Label ↗AP
2008-01-11Manufacturing (CMC) · Supplement 53AP
2006-07-26Efficacy · Supplement 46 · standard — Letter ↗AP
2005-09-30Manufacturing (CMC) · Supplement 45 · standard — Label ↗AP
2005-06-27Labeling · Supplement 44 · standard — Letter ↗AP
2005-03-15Labeling · Supplement 39 · standard — Letter ↗AP
2004-01-30Labeling · Supplement 38 · standard — Letter ↗AP
2003-05-01Labeling · Supplement 35 · standard — Label ↗AP
2003-04-28Efficacy · Supplement 33 · standard — Label ↗AP
2002-12-04Manufacturing (CMC) · Supplement 32 · standardAP
2002-10-10Manufacturing (CMC) · Supplement 31 · standardAP
2002-03-27Labeling · Supplement 15 · standard — Letter ↗AP
2002-03-15Manufacturing (CMC) · Supplement 30 · standardAP
2002-03-15Manufacturing (CMC) · Supplement 29 · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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