Overview
A synthetic fluoroquinolone (fluoroquinolones) with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin inhibits bacterial DNA gyrase.
Indication
For the treatment of urinary tract infection
Associated Conditions
- Cystitis
- Gonococcal cervicitis
- Infectious diarrhea
- Pyelitis
- Pyelonephritis
- Spontaneous Bacterial Peritonitis (SBP)
- Traveler's Diarrhea
- Urethritis gonococcal
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/14 | Phase 4 | Completed | |||
2024/01/10 | Not Applicable | Not yet recruiting | |||
2021/02/10 | Phase 3 | UNKNOWN | |||
2019/11/13 | Phase 3 | Recruiting | |||
2019/11/12 | Phase 3 | UNKNOWN | Ospedali Riuniti di Foggia | ||
2018/10/11 | Not Applicable | Completed | |||
2018/04/24 | Phase 4 | UNKNOWN | |||
2014/04/22 | Phase 3 | UNKNOWN | Sherief Abd-Elsalam | ||
2012/03/02 | Phase 4 | Completed | |||
2012/02/06 | Phase 3 | Withdrawn | Eurofarma Laboratorios S.A. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| LOXONE-400 TABLET 400 mg | SIN08998P | TABLET, FILM COATED | 400 mg | 11/7/1996 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Norfloxacin Glutamate and Sodium Chloride Injection | 国药准字H20065962 | 化学药品 | 注射剂 | 5/6/2020 | |
| Norfloxacin Glutamate and Sodium Chloride Injection | 国药准字H20053242 | 化学药品 | 注射剂 | 6/22/2020 | |
| Norfloxacin Ointment | 国药准字H10910027 | 化学药品 | 软膏剂 | 4/7/2020 | |
| Norfloxacin Ointment | 国药准字H53020047 | 化学药品 | 软膏剂 | 9/7/2020 | |
| Norfloxacin Ointment | 国药准字H20003608 | 化学药品 | 软膏剂 | 4/17/2020 | |
| Norfloxacin Ointment | 国药准字H10940120 | 化学药品 | 软膏剂 | 5/12/2020 | |
| Norfloxacin Ointment | 国药准字H53020395 | 化学药品 | 软膏剂 | 6/15/2020 | |
| Norfloxacin Ointment | 国药准字H53020048 | 化学药品 | 软膏剂 | 9/7/2020 | |
| Norfloxacin Ointment | 国药准字H10910028 | 化学药品 | 软膏剂 | 4/7/2020 | |
| Norfloxacin Glutamate Injection | 国药准字H20058169 | 化学药品 | 注射剂 | 7/13/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| APO-NORFLOXACIN norfloxacin 400 mg tablet bottle | 155546 | Medicine | A | 11/19/2008 | |
| ROXIN norfloxacin 400 mg tablet blister pack | 93210 | Medicine | A | 3/26/2003 | |
| CHEMMART NORFLOXACIN norfloxacin 400 mg tablet bottle | 155547 | Medicine | A | 11/19/2008 | |
| TERRY WHITE CHEMISTS NORFLOXACIN norfloxacin 400 mg tablet bottle | 155548 | Medicine | A | 11/19/2008 | |
| GENRX NORFLOXACIN norfloxacin 400mg tablet blister pack | 80662 | Medicine | A | 11/13/2001 | |
| GN-NORFLOXACIN norfloxacin 400mg tablet blister pack | 184276 | Medicine | A | 4/20/2012 | |
| LAXIFLOCIN norfloxacin 400mg tablet blister pack | 184275 | Medicine | A | 4/20/2012 |
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