Data updated: May 26, 2026
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) (amoxicillin)
Infectious Disease
Approved 2013-08-30
Amoxicillin and Clavulanate Potassium treats various bacterial infections in both adult and pediatric patients. It helps patients with infections of the lower respiratory tract, middle ear, and sinuses, as well as skin and urinary tract infections. This combination is used when bacteria produce beta-lactamase, an enzyme that can make some infections resistant to standard antibiotics. HOW_IT_
Source: FDA Label • RISING
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
Website: ↗
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) Approval History
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2013 to 2024
Jun 2024 SUPPL
Label · Labeling
Jun 2024 SUPPL
Label · Labeling
Jun 2024 SUPPL
Label · Labeling
May 2024 SUPPL
Label
Aug 2023 SUPPL
Label
Jul 2023 SUPPL
Label
Aug 2022 SUPPL
Label
Apr 2022 SUPPL
Label
Mar 2022 SUPPL
Label
Mar 2022 SUPPL
Label
Oct 2016 ORIGINAL
Update
Feb 2015 SUPPL
Label
Mar 2014 ORIGINAL
Update
Aug 2013 ORIGINAL
Update
What LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) Treats
5 indicationsLANSOPRAZOLE, 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
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) Competitive Set
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Clinical Trial Registry
116 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06921213 Cares-1 | 31732 | Ph 2 | recruiting | Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis |
| NCT06823154 | 1000069700 | Ph 1 | active not recruiting | The Implementation and Impact of an Allergy De-Labeling Program in the Emergency Department |
| NCT07275580 PRO-EXOD | 69108723.1.0000.0068 | Ph 4 | not yet recruiting | Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases |
| NCT06131021 PAAS | Pro2023001347 4UH3DE031129-02 | Ph 3 | completed | Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice |
| NCT06229288 CAPTAIN | RC20_0015 | Ph 3 | recruiting | Amoxicillin Alone Versus Amoxicillin/Clavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older, and Hospitalized in a Non-intensive Care Unit Ward |
| NCT07485010 FORMaT-EVOLVE | FORMaT002 | Ph 2 | not yet recruiting | Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial |
| NCT07457385 | CONSISTENT Pending | Ph 4 | not yet recruiting | Congenital Syphilis Treatment Trial (CONSISTENT) in Neonates |
| NCT06494072 | PRO00046965 | Ph 4 | recruiting | Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP |
| NCT05398679 OraPAT-IEGAMES | OraPAT-IE GAMES | Ph 4 | recruiting | Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis |
| NCT06340724 | KY20240123-08 | Ph 3 | completed | Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication |
| NCT07293910 | Helicobacter Pylori | Ph 2 | recruiting | Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection |
| NCT02701595 | RODEO 2 | Ph 3 | completed | Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus |
| NCT02281929 AntibioCor | 2014_05 2014-002536-13, PHRC-2013-0552 | Ph 3 | completed | Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone |
| NCT05309928 | IRB-300008691 UAB | Ph 1 | completed | Phase 1 Study of the Pharmacokinetics of Amoxicillin in Pregnancy |
| NCT07242456 TV-HP | TV-HP-2024-01 BCF-LX-XH-20221014-26 | Ph 2, Ph 3 | recruiting | Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication |
| NCT06010719 AMOUR | 23-39411 5R01HD111532 | Ph 4 | recruiting | Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition |
| NCT04728516 | 2020SDUCRCA006 | Ph 4 | recruiting | The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients |
| NCT05874544 | rjhy20230001 | Ph 4 | completed | Rescue Therapy for Helicobacter Pylori Infection |
| NCT02707042 | 160078 16-I-0078 | Ph 1 | completed | Microbial, Immune, and Metabolic Perturbations by Antibiotics (MIME Study) |
| NCT03273296 | 1341/6.00.00/2017 | Ph 4 | completed | Effect of Antibiotics on Gut Microbiome and Plasma Metabolome |
| NCT07068607 | KY20252096-F-1 | Ph 4 | recruiting | Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial |
| NCT06771492 ABBA | 2024-515824-35 2024-515824-35-01 | Ph 3 | recruiting | Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial |
| NCT06514274 | KY20242226-C-1 | Ph 4 | completed | Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication |
| NCT06168084 | KY20232236-F-2 | Ph 4 | completed | Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy |
| NCT05742568 | KY20222310-C-1 | Ph 4 | completed | Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology |
| NCT06523764 | KY20242230-C-1 | Ph 4 | active not recruiting | Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment |
| NCT03031210 | BID pneumonia | Ph 2, Ph 3 | recruiting | Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia. |
| NCT06964334 | vit D supplement h.pylori | Ph 3 | not yet recruiting | The Effect of Vitamin D Supplement as Adjuvant Therapy in Eradication of Helicobacter Pylori Infection |
| NCT06877351 AMOXSYP | 13246 | Ph 3 | active not recruiting | Oral Amoxicillin Compared to Penicillin G Benzathine for the Treatment of Acquired Syphilis. |
| NCT05473234 results posted | 22-36912 | Ph 3 | terminated | Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria |
| NCT06576882 VOTE-HP | 0306630 | Ph 3 | completed | 7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication |
| NCT04070469 MAX-AMOX | RBHP 2019 VIDAL (MAX-AMOX) 2019-002824-34 | Ph 4 | completed | Plasma Concentrations of Amoxicillin Administered in High-doses During the First Week of Treatment (MAX-AMOX) |
| NCT06709196 REINFORCE | 2024-514312-27-00 2024-514312-27-00 | Ph 4 | recruiting | Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis |
| NCT05901051 | rjyy20210815 | Ph 4 | completed | High-dose Dual Therapy with Different Administration Frequencies |
| NCT06561698 | rjhy20240814 | Ph 4 | recruiting | High-dose Dual Therapy and Minocycline-cotaining Quadruple Therapy for Helicobacter Pylori Infection |
| NCT05649540 | KY20221124-07 | Ph 4 | completed | Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori |
| NCT06613776 | CE032315 | Ph 4 | completed | Evaluation of the Effect of Antibiotic Prophylaxis (2g Amoxicillin One Hour Before Surgery) on an Inflammatory Factor (PGE2) in Salivary Samples After Third Molars Surgery |
| NCT05302531 GRAAL | 2021-001468-13 | Ph 1 | recruiting | Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome |
| NCT06162949 | 0306381 | Ph 3 | completed | Vonoprazan for Helicobacter Pylori Eradication in Adolescents |
| NCT05010304 results posted | STU-2021-0517 | Ph 4 | completed | Penicillin De-labeling in the Pediatric Primary Care Setting |
| NCT04552080 | Syst AB + Sinus 01 | Ph 4 | recruiting | The Effect of Systemic Antibiotics on Post-surgical Complications and Patient-centered Outcomes in Patients Undergoing Implant Surgery With Guided Bone Regeneration and Simultaneous Sinus Floor Elevation |
| NCT03060473 TREAT results posted | 16-0323 | Ph 3 | terminated | Treatment of ppROM With Erythromycin vs. Azithromycin Trial |
| NCT05469685 | KY20220701-06 | Ph 4 | completed | Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication |
| NCT03404804 OPEN results posted | 1069530-3 | Ph 4 | completed | Oral Challenge in the Pediatric ED |
| NCT06412640 | KY20240419-15 | Ph 4 | not yet recruiting | Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori |
| NCT05431075 | 2022-SDU-QILU-G004 | Ph 4 | completed | Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment of Different Tetracycline Doses |
| NCT06076694 results posted | TNP-2198-06 | Ph 2 | completed | Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants |
| NCT06076681 results posted | TNP-2198-04 | Ph 1, Ph 2 | completed | A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules |
| NCT05165212 | STUDY00006018 | Ph 4 | withdrawn | Primary Care Amoxicillin Challenge |
| NCT04198363 results posted | Vonoprazan-3002 | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection |
Showing 50 of 116 trials
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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.
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) FDA Label Details
Indications & Usage
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) is indicated for the treatment of Lower Respiratory Tract Infection; Acute Bacterial Otitis Media; Sinusitis; Skin and Skin Structure Infection; Urinary Tract Infection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.