SEROMYCIN
Details
- Status
- Prescription
- First Approved
- 1964-06-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE
SEROMYCIN Approval History
What SEROMYCIN Treats
2 indicationsSEROMYCIN is approved for 2 conditions since its original approval in 1964. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tuberculosis
- Urinary Tract Infection
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
SEROMYCIN FDA Label Details
ProIndications & Usage
Cycloserine is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis drugs, cycloserine should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent. Cycloserine may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram-positive and gram- negati...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.