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Data updated: Mar 10, 2026

CEPHALEXIN

CEPHALEXIN
Infectious Disease Approved 1976-04-26
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
33
Indications
--
Phase 3 Trials
49
Years on Market

Details

Status
Prescription
First Approved
1976-04-26
Routes
ORAL
Dosage Forms
FOR SUSPENSION, CAPSULE, TABLET

Companies

Teva VITARINE Sun Pharma Lupin YUNG SHIN PHARM Hikma ANDA REPOSITORY Aurobindo Pharma YOSHITOMI ALKEM LABS LTD FACTA FARMA PUREPAC PHARM APOTHECON STEVENS J IVAX SUB TEVA PHARMS AJENAT PHARMS CHARTWELL RX
Active Ingredient: CEPHALEXIN

CEPHALEXIN Approval History

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What CEPHALEXIN Treats

5 indications

CEPHALEXIN is approved for 5 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Respiratory Tract Infection
  • Otitis Media
  • Skin and Skin Structure Infection
  • Bone Infection
  • Genitourinary Tract Infection
Source: FDA Label

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

CEPHALEXIN FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Cephalexin capsules are a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection Otitis media Skin and skin structure infections Bone infections Genitourinary tract infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 1.1 Respiratory Tract Infections Cephalexin c...

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Data Sources

FDA Approval: ANDA062703 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.