NDA 206829, held by Cubist Pharms LLC. Ceftolozane Sulfate; Tazobactam Sodium.
As of Nov 13, 2026, NDA 206829 (Zerbaxa), held by Cubist Pharms LLC, was first approved by FDA on Dec 19, 2014, with 9 approved supplements and 0 published complete response letters.
ZERBAXA (ceftolozane and tazobactam) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible microorganisms in adult and pediatric patients (at least 32 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole. Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis. Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP).
| May 12, 2026 | Supplement 23Efficacy (new indication or use) · Priority review | Approved | |
| Apr 21, 2022 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Apr 21, 2022 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jun 3, 2019 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Dec 19, 2014 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZerbaxaEQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL · powder;intravenous | Ceftolozane Sulfate; Tazobactam Sodium | RxReference drug |
| May 12, 2026 | Supplement 23Efficacy (new indication or use) · Priority review | Approved | |
| Apr 21, 2022 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Apr 21, 2022 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Dec 13, 2019 | Supplement 9Labeling · Standard review | Approved | |
| Jun 3, 2019 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Nov 17, 2016 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Oct 26, 2016 | Supplement 3Labeling · Standard review | Approved | |
| Sep 6, 2016 | Supplement 2Labeling · Standard review | Approved | |
| May 20, 2015 | Supplement 1Labeling · Standard review | Approved | |
| Dec 19, 2014 | Original applicationNew molecular entity, new combination · Priority review | Approved |
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
