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Data updated: Mar 10, 2026

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)

AMOXICILLIN
Infectious Disease Approved 2013-08-30
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
12
Years on Market

Details

Status
Prescription
First Approved
2013-08-30
Routes
ORAL
Dosage Forms
CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS

Companies

Novartis ANI PHARMS RISING
Active Ingredient: AMOXICILLIN , CLARITHROMYCIN , LANSOPRAZOLE

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) Approval History

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What LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) Treats

5 indications

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) is approved for 5 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Lower Respiratory Tract Infection
  • Acute Bacterial Otitis Media
  • Sinusitis
  • Skin and Skin Structure Infection
  • Urinary Tract Infection
Source: FDA Label

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Trial Timeline

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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.

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) FDA Label Details

Pro

Indications & Usage

Amoxicillin and Clavulanate Potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections - caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . Skin and Skin Structure Infections - caused by beta‑la...

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Data Sources

FDA Approval: ANDA202588 → Label: DailyMed → Trials: ClinicalTrials.gov →

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