NDA 206056, held by B Braun Medical. Piperacillin Sodium; Tazobactam Sodium.
As of Nov 14, 2026, NDA 206056 (Piperacillin And Tazobactam And Sodium Chloride In Duplex Container), held by B Braun Medical, was first approved by FDA on Apr 3, 2025, with 0 approved supplements and 0 published complete response letters.
Piperacillin and Tazobactam for Injection and Sodium Chloride Injection, is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: Intra-abdominal infections in adult and pediatric patients 2 months of age and older Nosocomial pneumonia in adult and pediatric patients 2 months of age and older Skin and skin structure infections in adults Female pelvic infections in adults Community-acquired pneumonia in adults Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and Sodium Chlori…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 3, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Piperacillin And Tazobactam And Sodium Chloride In Duplex ContainerEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL · powder;intravenous | Piperacillin Sodium; Tazobactam Sodium | RxReference drug |
| Piperacillin And Tazobactam And Sodium Chloride In Duplex ContainerEQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL · powder;intravenous | Piperacillin Sodium; Tazobactam Sodium | RxReference drug |
| Piperacillin And Tazobactam And Sodium Chloride In Duplex ContainerEQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL · powder;intravenous | Piperacillin Sodium; Tazobactam Sodium | RxReference drug |
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
