NITROFURANTOIN
Details
- Status
- Prescription
- First Approved
- 1970-11-25
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, SUSPENSION
Companies
NITROFURANTOIN Approval History
What NITROFURANTOIN Treats
1 indicationsNITROFURANTOIN is approved for 1 conditions since its original approval in 1970. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urinary Tract Infection
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Active Pipeline
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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.
NITROFURANTOIN FDA Label Details
ProIndications & Usage
1 INDICATIONS & USAGE Nitrofurantoin is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli , Enterococcus species, Staphylococcus aureus , Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions ]. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin and other antibacterial drugs, nitrofurantoin should ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.