NORETHINDRONE ACETATE
Details
- Status
- Prescription
- First Approved
- 2001-05-25
- Routes
- ORAL
- Dosage Forms
- TABLET
NORETHINDRONE ACETATE Approval History
What NORETHINDRONE ACETATE Treats
3 indicationsNORETHINDRONE ACETATE is approved for 3 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Secondary Amenorrhea
- Endometriosis
- Abnormal Uterine Bleeding
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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.
NORETHINDRONE ACETATE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Norethindrone Acetate Tablets, USP are indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Norethindrone Acetate Tablets, USP are not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.