← FDA DRUG APPROVALS

FDA NDA · NDA206829

ZERBAXA

ceftolozane and tazobactam

Sponsor: CUBIST PHARMS LLC

APPLICATION
NDA206829
TYPE
NDA
ORIGINAL APPROVAL
2014-12-19
LATEST ACTION
2026-05-12
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ZERBAXA · ReferencePrescription
CEFTOLOZANE SULFATE EQ 1GM BASE/VIAL, TAZOBACTAM SODIUM EQ 0.5GM BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2026-05-12Efficacy · Supplement 23 · priority — Letter ↗AP
2022-04-21Efficacy · Supplement 11 · standard — Letter ↗AP
2022-04-21Efficacy · Supplement 12 · standard — Letter ↗AP
2019-12-13Labeling · Supplement 9 · standard — Label ↗AP
2019-06-03Efficacy · Supplement 8 · priority — Letter ↗AP
2016-11-17Manufacturing (CMC) · Supplement 4 · standardAP
2016-10-26Labeling · Supplement 3 · standard — Letter ↗AP
2016-09-06Labeling · Supplement 2 · standard — Letter ↗AP
2015-05-20Labeling · Supplement 1 · standard — Label ↗AP
2014-12-19Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
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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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