AMOXICILLIN AND CLAVULANATE POTASSIUM
Details
- Status
- Prescription
- First Approved
- 2002-03-14
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, FOR SUSPENSION, TABLET, CHEWABLE
Companies
AMOXICILLIN AND CLAVULANATE POTASSIUM Approval History
What AMOXICILLIN AND CLAVULANATE POTASSIUM Treats
37 FDA approvalsOriginally approved for its first indication in 2002 . Covers 37 distinct patient populations.
- Other (37)
Other
(37 approvals)- • Approved indication (Mar 2002)Letter
- • Approved indication (Mar 2002)Letter
- • Approved indication (Apr 2002)Letter
- • Approved indication (Jun 2002)Letter
- • Approved indication (Sep 2002)
- • Approved indication (Oct 2002)
- • Approved indication (Oct 2002)
- • Approved indication (Nov 2002)
- • Approved indication (Nov 2002)
- • Approved indication (Nov 2002)
- • Approved indication (Dec 2002)
- • Approved indication (Mar 2003)
- • Approved indication (Dec 2003)
- • Approved indication (Mar 2004)
- • Approved indication (May 2004)
- • Approved indication (Jan 2005)
- • Approved indication (Feb 2005)
- • Approved indication (Aug 2005)
- • Approved indication (Jan 2007)
- • Approved indication (Aug 2007)
- • Approved indication (Nov 2007)
- • Approved indication (Oct 2008)
- • Approved indication (Nov 2008)Letter
- • Approved indication (Feb 2009)
- • Approved indication (Apr 2010)Letter
- • Approved indication (Dec 2011)
- • Approved indication (Jan 2012)
- • Approved indication (Dec 2013)
- • Approved indication (Aug 2016)
- • Approved indication (Dec 2016)
- • Approved indication (Apr 2019)Letter
- • Approved indication (May 2021)
- • Approved indication (Sep 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Nov 2023)
- • Approved indication (Dec 2023)
- • Approved indication (Dec 2023)
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.
AMOXICILLIN AND CLAVULANATE POTASSIUM FDA Label Details
ProIndications & Usage
FDA Label (PDF)To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.