TERCONAZOLE
Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.
Details
- Status
- Prescription
- First Approved
- 2004-04-06
- Routes
- VAGINAL
- Dosage Forms
- SUPPOSITORY, CREAM
TERCONAZOLE Approval History
What TERCONAZOLE Treats
7 FDA approvalsOriginally approved for its first indication in 2004 . Covers 7 distinct patient populations.
- Other (7)
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02308007 SMART GIVES results posted | MTC-001 (Trial 3) | Ph 3 | completed | Multi-Center Study of New Medications to Treat Vaginal Infections |
| NCT02308046 SMART GIVES results posted | MTC-001 (Trial 1) | Ph 3 | completed | Multi-Center Study of New Medications to Treat Vaginal Infections |
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.
TERCONAZOLE FDA Label Details
Indications & Usage
FDA Label (PDF)Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.
Looking for the branded version?
TERAZOL 3
Full clinical data, patents, trials, and competitive landscape for terconazole.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.