← FDA DRUG APPROVALS

FDA NDA · NDA050750

ZOSYN IN GALAXY CONTAINERS

tazobactam sodium and piperacillin sodium

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA050750
TYPE
NDA
ORIGINAL APPROVAL
1998-02-24
LATEST ACTION
2024-12-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZOSYN IN PLASTIC CONTAINER · ReferencePrescription
PIPERACILLIN SODIUM EQ 60MG BASE/ML, TAZOBACTAM SODIUM EQ 7.5MG BASE/ML · INJECTABLE · INJECTION
ZOSYN IN PLASTIC CONTAINER · ReferencePrescription
PIPERACILLIN SODIUM EQ 4GM BASE/100ML, TAZOBACTAM SODIUM EQ 500MG BASE/100ML · INJECTABLE · INJECTION
ZOSYN IN PLASTIC CONTAINER · ReferencePrescription
PIPERACILLIN SODIUM EQ 40MG BASE/ML, TAZOBACTAM SODIUM EQ 5MG BASE/ML · INJECTABLE · INJECTION

Approval history

2024-12-03Labeling · Supplement 53 · standard — Letter ↗AP
2024-11-19Labeling · Supplement 54 · standard — Letter ↗AP
2024-05-01Labeling · Supplement 51 · standard — Letter ↗AP
2024-04-11Manufacturing (CMC) · Supplement 50 — Letter ↗AP
2022-12-16Labeling · Supplement 49 · standard — Label ↗AP
2022-04-08Labeling · Supplement 47 · standard — Letter ↗AP
2022-03-23Labeling · Supplement 48 · standard — Letter ↗AP
2021-07-29Labeling · Supplement 45 · standard — Letter ↗AP
2020-05-26Efficacy · Supplement 43 · standard — Label ↗AP
2020-04-13Labeling · Supplement 42 · standard — Letter ↗AP
2019-05-10Labeling · Supplement 41 · standard — Letter ↗AP
2017-05-05Labeling · Supplement 39 · standard — Label ↗AP
2017-05-05Labeling · Supplement 37 · standard — Label ↗AP
2017-05-05Labeling · Supplement 38 · standard — Label ↗AP
2016-06-10Labeling · Supplement 35 · standard — Label ↗AP
2016-06-10Labeling · Supplement 34 · standard — Label ↗AP
2015-12-18Labeling · Supplement 33 · standard — Label ↗AP
2014-07-17Manufacturing (CMC) · Supplement 31 · standardAP
2014-06-24Manufacturing (CMC) · Supplement 32 · standardAP
2013-09-06Labeling · Supplement 21 · standard — Label ↗AP
2013-09-06Labeling · Supplement 26 · standard — Label ↗AP
2013-09-06Labeling · Supplement 30 · standard — Label ↗AP
2013-06-18Manufacturing (CMC) · Supplement 28 · standardAP
2012-05-11Labeling · Supplement 20 · standard — Label ↗AP
2012-05-11Labeling · Supplement 16 · standard — Label ↗AP
2011-09-28Labeling · Supplement 24 · standard — Label ↗AP
2008-04-17Labeling · Supplement 15 · standard — Label ↗AP
2006-07-26Efficacy · Supplement 14 · standard — Label ↗AP
2005-09-30Manufacturing (CMC) · Supplement 12 · standard — Label ↗AP
2005-06-27Labeling · Supplement 11 · standard — Letter ↗AP
2005-03-15Labeling · Supplement 9 · standard — Letter ↗AP
2003-05-06Efficacy · Supplement 8 · standard — Label ↗AP
2003-05-06Labeling · Supplement 7 · standard — Label ↗AP
2002-03-27Labeling · Supplement 3 · standard — Letter ↗AP
2002-03-14Manufacturing (CMC) · Supplement 5 · standardAP
2001-02-01Manufacturing (CMC) · Supplement 4 · standardAP
1998-07-13Manufacturing (CMC) · Supplement 1 · standardAP
1998-02-24Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →