Data updated: Mar 10, 2026
SARAFEM
FLUOXETINE HYDROCHLORIDE
Approved 1987-12-29
10
Indications
--
Phase 3 Trials
2
Priority Reviews
38
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1987-12-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
SARAFEM Approval History
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What SARAFEM Treats
10 FDA approvalsOriginally approved for its first indication in 1987 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (Dec 1987) Priority
- • Approved indication (Nov 1996)
- • Approved indication (Jul 2000)Label Letter
- • Approved indication (Jun 2002)Label Letter
- • Approved indication (Jul 2002)
- • Approved indication (Jan 2003)Label Letter
- • Approved indication (May 2006)Label Letter
- • Approved indication (Mar 2009) PriorityLabel Letter
- • Approved indication (Jul 2013)Label Letter
- • Approved indication (Oct 2014)Label Letter
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
SARAFEM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.