Overview
An anti-infective agent that is used topically to treat skin infections and orally for urinary tract infections.
Indication
For the treatment of bacterial vaginitis, keratitis, acute conjunctivitis, and blepharitis.
Associated Conditions
- Acne Vulgaris
- Conjunctivitis
- Trachoma
- Superficial ocular infections
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/10/06 | Phase 4 | Completed | Joseph B. Ciolino, MD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Gabar Health Sciences Corp. | 82429-107 | TOPICAL | 10 mg in 1 g | 10/21/2023 | |
| Eckson Labs LLC | 44118-701 | TOPICAL | 98 mg in 1 g | 3/30/2022 | |
| Keltman Pharmaceuticals Inc. | 68387-491 | OPHTHALMIC | 100 mg in 1 mL | 7/12/2010 | |
| Brava Pharmaceuticals, LLC | 57883-404 | TOPICAL | 98 mg in 1 g | 12/26/2019 | |
| BioComp Pharma, Inc. | 44523-520 | TOPICAL | 100 mg in 1 g | 8/16/2023 | |
| BioComp Pharma, Inc. | 44523-602 | TOPICAL | 100 mg in 1 g | 3/23/2023 | |
| Acella Pharmaceuticals, LLC | 42192-133 | TOPICAL | 80 mg in 1 mL | 9/11/2018 | |
| Sandoz Inc. | 61314-701 | OPHTHALMIC | 100 mg in 1 mL | 8/5/2011 | |
| KMM Pharmaceuticals, LLC | 52187-553 | TOPICAL | 98 mg in 1 mL | 2/14/2022 | |
| Eckson Labs, LLC | 44118-712 | TOPICAL | 98 mg in 1 mL | 2/10/2022 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| VASOSULF OPH SOLN | iolab pharmaceuticals | 00760048 | Drops - Ophthalmic | 150 MG / ML | 12/31/1988 |
| PREDNISOLONE/SULFACETAMIDE | pharma stulln inc. | 02023814 | Suspension - Ophthalmic | 10 % / W/V | 12/31/1994 |
| CETAMIDE ONT 10% | Alcon Canada Inc | 00252522 | Ointment - Ophthalmic | 10 % | 12/31/1972 |
| VASOCIDIN OPHTHALMIC SOLUTION | iolab pharmaceuticals | 00843741 | Liquid - Ophthalmic | 100 MG / ML | 12/31/1992 |
| VASOCIDIN OPHTHALMIC SOLUTION | novartis ophthalmics novartis pharmaceuticals (canada) inc | 02133342 | Solution - Ophthalmic | 100 MG / ML | 12/31/1996 |
| BLEPHAMIDE S.O.P. | 00307246 | Ointment - Ophthalmic | 10 % | 12/31/1974 | |
| SULFEX 10% | laboratoires charton laboratories | 00554022 | Liquid - Ophthalmic | 10 % | 12/31/1982 |
| ODAN-SULFACETAMIDE | odan laboratories ltd | 00622966 | Solution - Ophthalmic | 10 % | 12/31/1985 |
| METIMYD OPH SUS | schering-plough canada inc | 00177024 | Suspension - Ophthalmic | 100 MG / ML | 12/31/1956 |
| SODIUM SULAMYD OPH DPS 30% | schering-plough canada inc | 00028061 | Drops - Ophthalmic | 300 MG / ML | 12/31/1951 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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