Overview
Amoxicillin, or BRL-2333, is a penicillin G derivative first described in the literature in 1972. Amoxicillin has similar activity to penicillin and ampicillin, but leads to higher serum concentrations than ampicillin. Amoxicillin was granted FDA approval on 18 January 1974.
Background
Amoxicillin, or BRL-2333, is a penicillin G derivative first described in the literature in 1972. Amoxicillin has similar activity to penicillin and ampicillin, but leads to higher serum concentrations than ampicillin. Amoxicillin was granted FDA approval on 18 January 1974.
Indication
Amoxicillin alone is indicated to treat susceptible bacterial infections of the ear, nose, throat, genitourinary tract, skin, skin structure, and lower respiratory tract. Amoxicillin is given with calvulanic acid to treat acute bacterial sinusitis, community acquired pneumonia, lower respiratory tract infections, acute bacterial otitis media, skin and skin structure infections, and urinary tract infections. Amoxicillin is given with omeprazole in the treatment of Helicobacter pylori (H. pylori) infection. Amoxicillin is used in combination with vonoprazan and clarithromycin as co-packaged triple therapy or in combination with vonoprazan as co-packaged dual therapy to treat H. pylori infection in adults.
Associated Conditions
- Acute Bacterial Sinusitis (ABS)
- Acute Otitis Media (AOM)
- Bacterial Infections
- Community Acquired Pneumonia (CAP)
- Duodenal ulcer caused by helicobacter pylori
- Genitourinary tract infection
- Helicobacter Pylori Infection
- Lower Respiratory Tract Infection (LRTI)
- Peptic Ulcer With H. Pylori Infection
- Sinusitis
- Skin and Subcutaneous Tissue Bacterial Infections
- Urinary Tract Infection
- Acute, uncomplicated Gonorrhea
- Ear, nose, and throat infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/09 | Phase 3 | Not yet recruiting | |||
2025/04/10 | Phase 2 | Not yet recruiting | |||
2025/03/28 | Early Phase 1 | Not yet recruiting | |||
2025/03/14 | Phase 3 | Active, not recruiting | Hospital de Niños R. Gutierrez de Buenos Aires | ||
2025/03/11 | Not Applicable | Not yet recruiting | |||
2025/02/28 | Not Applicable | Not yet recruiting | Key Laboratory for Gastrointestinal Diseases of Gansu Province | ||
2025/02/12 | Phase 1 | Active, not recruiting | |||
2025/02/06 | Phase 3 | ENROLLING_BY_INVITATION | Chang Gung Memorial Hospital | ||
2025/01/16 | Early Phase 1 | Not yet recruiting | |||
2025/01/13 | Phase 3 | Recruiting | Bart Koes |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-6355 | ORAL | 400 mg in 5 mL | 12/12/2022 | |
| Proficient Rx LP | 63187-044 | ORAL | 500 mg in 1 1 | 11/1/2018 | |
| Bryant Ranch Prepack | 63629-7798 | ORAL | 500 mg in 1 1 | 12/14/2015 | |
| NuCare Pharmaceuticals,Inc. | 68071-4696 | ORAL | 125 mg in 5 mL | 2/17/2021 | |
| Preferred Pharmaceuticals Inc. | 68788-7958 | ORAL | 875 mg in 1 1 | 2/8/2024 | |
| A-S Medication Solutions | 50090-1814 | ORAL | 250 mg in 5 mL | 6/7/2023 | |
| Direct_Rx | 61919-716 | ORAL | 250 mg in 5 mL | 1/12/2023 | |
| NuCare Pharmaceuticals,Inc. | 68071-2323 | ORAL | 250 mg in 1 1 | 1/6/2021 | |
| Pharmasource Meds, LLC | 82982-069 | ORAL | 875 mg in 1 1 | 5/26/2023 | |
| Aidarex Pharmaceuticals LLC | 33261-726 | ORAL | 250 mg in 5 mL | 3/28/2014 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BETAMOX GRANULES 125 mg/5 ml | SIN04143P | GRANULE, FOR SUSPENSION | 125 mg/5 ml | 4/20/1990 | |
| MOXICLAV DRY POWDER FOR ORAL SUSPENSION 156.25 mg/5 ml | SIN10690P | POWDER, FOR SUSPENSION | 125 mg/5 ml | 1/20/1999 | |
| CLAMOVID 625 TABLET 625 mg | SIN12026P | TABLET, FILM COATED | 500 mg | 7/17/2002 | |
| AMOXICAP 500 CAPSULE 500 mg | SIN09681P | CAPSULE | 500 mg | 3/19/1998 | |
| STRIMOX-250 CAPSULE 250 mg | SIN11417P | CAPSULE | 250 mg | 10/28/2000 | |
| PULMOXYL DRY SYRUP 125 mg/5ml | SIN11300P | SYRUP | 125 mg/5ml | 4/5/2000 | |
| AMOXIGRAN GRANULES 125 mg/5 ml | SIN07648P | GRANULE, FOR SUSPENSION | 125 mg/5 ml | 2/16/1994 | |
| PULMOXYL - 500 CAPSULE 500 mg (Maroon/yellow) | SIN11190P | CAPSULE | 500.00 mg | 9/24/1999 | |
| AMOXAPEN 250 CAPSULE 250 mg | SIN01607P | CAPSULE | 250 mg | 6/1/1988 | |
| AMOXAPEN 500 CAPSULE 500 mg | SIN01943P | CAPSULE | 500 mg | 6/23/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Amoxicillin Orally Disintegrating Tablets | 国药准字H20080277 | 化学药品 | 片剂 | 1/13/2023 | |
| Amoxicillin Sodium for Injection | 国药准字H20253300 | 化学药品 | 注射剂 | 1/24/2025 | |
| Amoxicillin Sodium for Injection | 国药准字H20253299 | 化学药品 | 注射剂 | 1/24/2025 | |
| Amoxicillin Sodium for Injection | 国药准字H20253301 | 化学药品 | 注射剂 | 1/24/2025 | |
| Amoxicillin Sodium for Injection | 国药准字H14020690 | 化学药品 | 注射剂 | 7/28/2020 | |
| Amoxicillin Sodium for Injection | 国药准字H20023124 | 化学药品 | 注射剂(无菌分装粉针剂) | 4/13/2020 | |
| Amoxicillin Sodium for Injection | 国药准字H20034100 | 化学药品 | 注射剂（无菌分装粉针剂） | 6/22/2020 | |
| Amoxicillin Sodium for Injection | 国药准字H20020449 | 化学药品 | 注射剂 | 2/7/2020 | |
| Amoxicillin Sodium for Injection | 国药准字H43022048 | 化学药品 | 注射剂 | 8/30/2023 | |
| Amoxicillin Sodium for Injection | 国药准字H20044607 | 化学药品 | 注射剂 | 5/21/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||