CRINONE
Details
- Status
- Prescription
- First Approved
- 1997-05-13
- Routes
- VAGINAL
- Dosage Forms
- GEL
CRINONE Approval History
What CRINONE Treats
3 indicationsCRINONE is approved for 3 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Infertility
- Progesterone Deficiency
- Secondary Amenorrhea
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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.
CRINONE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Assisted Reproductive Technology Crinone 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency. Secondary Amenorrhea Crinone 4% is indicated for the treatment of secondary amenorrhea. Crinone 8% is indicated for use in women who have failed to respond to treatment with Crinone 4%.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.