PIPERACILLIN AND TAZOBACTAM
Details
- Status
- Prescription
- First Approved
- 2009-09-15
- Routes
- INJECTION, POWDER,FOR SOLUTION
- Dosage Forms
- INJECTABLE, INJECTION
PIPERACILLIN AND TAZOBACTAM Approval History
What PIPERACILLIN AND TAZOBACTAM Treats
16 FDA approvalsOriginally approved for its first indication in 2009 . Covers 16 distinct patient populations.
- Other (16)
Other
(16 approvals)- • Approved indication (Sep 2009)Label Letter
- • Approved indication (Oct 2010)
- • Approved indication (May 2011)
- • Approved indication (May 2011)
- • Approved indication (Aug 2014)
- • Approved indication (Oct 2014)
- • Approved indication (Jan 2017)
- • Approved indication (Mar 2017)
- • Approved indication (Mar 2017)
- • Approved indication (May 2018)
- • Approved indication (May 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Jul 2019)
- • Approved indication (Feb 2021)
- • Approved indication (Apr 2023)
- • Approved indication (Oct 2023)
PIPERACILLIN AND TAZOBACTAM Boxed Warning
PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION...
PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PIPERACILLIN AND TAZOBACTAM FDA Label Details
ProIndications & Usage
FDA Label (PDF)Piperacillin and tazobactam for injection, for intravenous use is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a β-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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and T...
PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.