Data updated: Mar 10, 2026
CEFADROXIL
CEFADROXIL/CEFADROXIL HEMIHYDRATE
Approved 1980-07-30
20
Indications
--
Phase 3 Trials
45
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1980-07-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE, FOR SUSPENSION, TABLET
Companies
Teva PUREPAC PHARM APOTHECON IVAX SUB TEVA PHARMS Novartis Hikma CHARTWELL RX RANBAXY Sun Pharma ANI PHARMS RANBAXY LABS LTD Aurobindo Pharma Lupin CSPC OUYI
Active Ingredient: CEFADROXIL/CEFADROXIL HEMIHYDRATE
Website: ↗
CEFADROXIL Approval History
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What CEFADROXIL Treats
20 FDA approvalsOriginally approved for its first indication in 1980 . Covers 20 distinct patient populations.
- Other (20)
Other
(20 approvals)- • Approved indication (Jul 1980)
- • Approved indication (Mar 1987)
- • Approved indication (Apr 1987)
- • Approved indication (Jan 1989)
- • Approved indication (Feb 1989)
- • Approved indication (Mar 1989)
- • Approved indication (Apr 1999)Letter
- • Approved indication (Jun 1999)Letter
- • Approved indication (Mar 2003)Label Letter
- • Approved indication (Jan 2006)
- • Approved indication (Feb 2006)
- • Approved indication (Mar 2006)
- • Approved indication (Sep 2006)
- • Approved indication (Oct 2006)
- • Approved indication (Jan 2007)
- • Approved indication (May 2007)
- • Approved indication (Feb 2008)Label Letter
- • Approved indication (Nov 2012)
- • Approved indication (Apr 2013)
- • Approved indication (Jul 2017)
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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.
CEFADROXIL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.