MACRODANTIN
Details
- Status
- Prescription
- First Approved
- 1970-06-05
- Routes
- ORAL
- Dosage Forms
- CAPSULE
MACRODANTIN Approval History
What MACRODANTIN Treats
3 indicationsMACRODANTIN is approved for 3 conditions since its original approval in 1970. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urinary Tract Infection
- Pyelonephritis
- Perinephric Abscess
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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.
MACRODANTIN FDA Label Details
ProIndications & Usage
FDA Label (PDF)Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli , enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin and other antibacterial drugs, Macrodantin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.