Data updated: Mar 10, 2026
CEFACLOR
CEFACLOR
Approved 1979-04-23
15
Indications
--
Phase 3 Trials
46
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1979-04-23
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION, CAPSULE, TABLET, EXTENDED RELEASE
Companies
IVAX SUB TEVA PHARMS WATSON LABS INC Teva DAVA PHARMS INC CHARTWELL RX FACTA FARMA RANBAXY WORLD GEN YUNG SHIN PHARM CEPH INTL Hikma
Active Ingredient: CEFACLOR
Website: ↗
CEFACLOR Approval History
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What CEFACLOR Treats
15 FDA approvalsOriginally approved for its first indication in 1979 . Covers 15 distinct patient populations.
- Other (15)
Other
(15 approvals)- • Approved indication (Apr 1979)
- • Approved indication (Jul 1979)
- • Approved indication (Apr 1995)
- • Approved indication (Apr 1995)
- • Approved indication (May 1996)
- • Approved indication (Jun 1996)
- • Approved indication (Sep 1996)Label Letter
- • Approved indication (Aug 1997)
- • Approved indication (Oct 1997)
- • Approved indication (Feb 1998)
- • Approved indication (Jan 2001)
- • Approved indication (Sep 2002)
- • Approved indication (Jan 2004)
- • Approved indication (Apr 2007)
- • Approved indication (Feb 2012)
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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.
CEFACLOR FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.