Data updated: Mar 10, 2026
AMOXICILLIN
AMOXICILLIN
Approved 1976-02-09
35
Indications
--
Phase 3 Trials
50
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1976-02-09
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION, TABLET, CHEWABLE, CAPSULE, TABLET, TABLET, FOR SUSPENSION
Companies
CHARTWELL RX Teva Hikma CHARTWELL Sun Pharma Novartis Aurobindo Pharma STRIDES PHARMA INTL Viatris PH HEALTH LABS ATRAL MICRO LABS APOTHECON
Active Ingredient: AMOXICILLIN
Website: ↗
AMOXICILLIN Approval History
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What AMOXICILLIN Treats
35 FDA approvalsOriginally approved for its first indication in 1976 . Covers 35 distinct patient populations.
- Other (35)
Other
(35 approvals)- • Approved indication (Feb 1976)
- • Approved indication (Aug 1978)
- • Approved indication (Dec 1978)
- • Approved indication (Dec 1982)
- • Approved indication (Aug 1985)
- • Approved indication (Dec 1987)
- • Approved indication (Feb 1988)
- • Approved indication (Nov 1988)
- • Approved indication (Nov 1988)
- • Approved indication (Jan 1989)
- • Approved indication (Feb 1989)
- • Approved indication (Dec 1992)
- • Approved indication (Sep 1994)
- • Approved indication (Jan 1996)
- • Approved indication (Dec 1996)
- • Approved indication (Apr 1999)Letter
- • Approved indication (Dec 1999)Letter
- • Approved indication (Sep 2000)Letter
- • Approved indication (Nov 2000)Label Letter
- • Approved indication (Nov 2000)Letter
- • Approved indication (Nov 2002)
- • Approved indication (Dec 2002)
- • Approved indication (Jul 2005)
- • Approved indication (Nov 2005)
- • Approved indication (Mar 2006)
- • Approved indication (Jun 2006)
- • Approved indication (Dec 2006)
- • Approved indication (Jan 2007)
- • Approved indication (Feb 2007)
- • Approved indication (Mar 2007)
- • Approved indication (Jun 2007)
- • Approved indication (Jan 2009)
- • Approved indication (Sep 2014)
- • Approved indication (Jun 2020)
- • Approved indication (Jun 2022)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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 FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.