Overview
Ampicillin is a semi-synthetic derivative of penicillin that functions as an orally active broad-spectrum antibiotic.
Indication
For treatment of infection (Respiratory, GI, UTI and meningitis) due to E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, nonpenicillinase-producing N. gononhoeae, H. influenzae, staphylococci, streptococci including streptoc
Associated Conditions
- Bacterial Infections
- Endocarditis
- Gastrointestinal Tract Infections
- Genitourinary tract infection
- Infection
- Infection caused by eikenella corrodens
- Listeria infection
- Meningitis, Bacterial
- Pertussis
- Respiratory Tract Infections (RTI)
- Salmonella
- Septicemia
- Shigella
- Subcutaneous bacterial infection
- Urinary Tract Infection
- Bacterial skin infections
- Disease caused by Salmonella typhi
- Perinatal group B streptococcus
- Susceptible Bacterial Infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/10 | Phase 4 | Recruiting | |||
2024/06/07 | Phase 4 | Completed | |||
2024/05/02 | Phase 4 | Recruiting | |||
2024/04/16 | Phase 4 | Recruiting | Uji Takeda Hospital | ||
2023/08/04 | Phase 3 | Not yet recruiting | |||
2022/07/22 | Not Applicable | Not yet recruiting | |||
2021/09/21 | Phase 2 | UNKNOWN | |||
2021/08/25 | Phase 2 | Recruiting | |||
2019/12/17 | Not Applicable | Completed | |||
2019/08/01 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 65219-018 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 1 1 | 1/24/2020 | |
| NorthStar Rx, LLC | 72603-220 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 1 1 | 2/28/2024 | |
| NorthStar Rx, LLC | 72603-454 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 2/22/2024 | |
| Medical Purchasing Solutions, LLC | 71872-7240 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 5/8/2023 | |
| Medical Purchasing Solutions, LLC | 71872-7286 | INTRAVENOUS | 1 g in 1 1 | 5/2/2023 | |
| Sandoz Inc | 0781-3402 | INTRAVENOUS, INTRAMUSCULAR | 250 mg in 1 1 | 10/20/2017 | |
| Methapharm, Inc. | 67850-131 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 1 1 | 1/21/2022 | |
| Eugia US LLC | 55150-114 | INTRAVENOUS | 2 g in 1 1 | 1/23/2024 | |
| WG Critical Care, LLC | 44567-211 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 20 mL | 2/23/2023 | |
| Physicians Total Care, Inc. | 54868-3113 | ORAL | 500 mg in 1 1 | 6/5/2012 |
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 |
|---|---|---|---|---|---|
| STANDACILLIN FOR INJECTION 0.5 g/vial | SIN00680P | INJECTION, POWDER, FOR SOLUTION | 500 mg/vial | 5/3/1988 | |
| UNASYN 750 FOR INJECTION | SIN01950P | INJECTION, POWDER, FOR SOLUTION | 500 mg/vial | 6/23/1988 | |
| UNASYN 3000 FOR INJECTION | SIN01949P | INJECTION, POWDER, FOR SOLUTION | 2 g/vial | 6/23/1988 | |
| UNASYN 1500 FOR INJECTION | SIN01948P | INJECTION, POWDER, FOR SOLUTION | 1 g/vial | 6/23/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ampicillin Tablets | 国药准字H52020767 | 化学药品 | 片剂 | 7/16/2020 | |
| Ampicillin Tablets | 国药准字H23022522 | 化学药品 | 片剂(素片) | 6/29/2020 | |
| Ampicillin Tablets | 国药准字H13024279 | 化学药品 | 片剂 | 8/17/2020 | |
| Ampicillin Tablets | 国药准字H37023735 | 化学药品 | 片剂 | 4/2/2020 | |
| Ampicillin Tablets | 国药准字H13024192 | 化学药品 | 片剂 | 8/26/2020 | |
| Ampicillin Tablets | 国药准字H23022523 | 化学药品 | 片剂 | 6/29/2020 | |
| Ampicillin for Suspension | 国药准字H21023783 | 化学药品 | 口服混悬剂 | 5/30/2023 | |
| Ampicillin Capsules | 国药准字H41025151 | 化学药品 | 胶囊剂 | 7/9/2020 | |
| Ampicillin Capsules | 国药准字H50021651 | 化学药品 | 胶囊剂 | 5/5/2020 | |
| Ampicillin Capsules | 国药准字H53021743 | 化学药品 | 胶囊剂 | 7/22/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| NEO A.C.2 CAP | N/A | N/A | N/A | 12/16/1985 | |
| LOXAMP CAPSULES | N/A | N/A | N/A | 5/22/2015 | |
| KINTAMVY FOR INJ 0.75G | N/A | N/A | N/A | 11/19/2007 | |
| REICHLOX CAP 500MG | N/A | N/A | N/A | 3/14/2005 | |
| REICHLIN CAP 250MG | N/A | N/A | N/A | 1/7/2005 | |
| AMPICILLIN SODIUM FOR INJ 0.5G | N/A | N/A | N/A | 8/15/2008 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Austrapen 1g powder for injection vial | 29354 | Medicine | A | 11/4/1991 | |
| IBIMICYN ampicillin 1g (as sodium) powder for injection vial | 92840 | Medicine | A | 2/20/2003 | |
| IBIMICYN ampicillin 500mg (as sodium) powder for injection vial | 92839 | Medicine | A | 2/20/2003 |
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