Data updated: Mar 10, 2026
FLUOXETINE HYDROCHLORIDE
FLUOXETINE HYDROCHLORIDE
Approved 2001-08-02
48
Indications
--
Phase 3 Trials
24
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2001-08-02
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, SOLUTION, CAPSULE, DELAYED REL PELLETS
Companies
NATCO PHARMA USA ACCORD HLTHCARE Dr. Reddy's Teva CHARTWELL MOLECULAR TORRENT CADILA PHARMS LTD INVENTIA HLTHCARE SCIEGEN PHARMS Lupin MARKSANS PHARMA LANDELA PHARM REGCON HOLDINGS LANNETT CO INC Aurobindo Pharma CARLSBAD Sun Pharma CHARTWELL RX ALEMBIC PHARMS LTD PH HEALTH CR DOUBLE CRANE ANI PHARMS STRIDES PHARMA INTL HERITAGE MICRO LABS NOVITIUM PHARMA PHARMOBEDIENT CNSLTG SPECGX LLC PHARM ASSOC G AND W LABS INC SENORES PHARMS SOLIS PHARMS IVAX SUB TEVA PHARMS Novartis PHARMOBEDIENT SOMERSET THERAPS LLC STRIDES PHARMA TWI PHARMS ALEMBIC UPSHER SMITH LABS RISING BAJAJ FOSUN PHARMA
Active Ingredient: FLUOXETINE HYDROCHLORIDE
Website: ↗
FLUOXETINE HYDROCHLORIDE Approval History
Loading approval history...
What FLUOXETINE HYDROCHLORIDE Treats
48 FDA approvalsOriginally approved for its first indication in 2001 . Covers 48 distinct patient populations.
- Other (48)
Other
(48 approvals)- • Approved indication (Aug 2001)Label Letter
- • Approved indication (Jan 2002)Label Letter
- • Approved indication (Jan 2002)
- • Approved indication (Jan 2002)Letter
- • Approved indication (Feb 2002)Letter
- • Approved indication (Feb 2002)Letter
- • Approved indication (Feb 2002)
- • Approved indication (Jun 2002)
- • Approved indication (Aug 2002)
- • Approved indication (May 2004)
- • Approved indication (Dec 2004)
- • Approved indication (Dec 2004)
- • Approved indication (May 2005)
- • Approved indication (Feb 2007)
- • Approved indication (Jan 2008)
- • Approved indication (Jan 2008)
- • Approved indication (May 2008)Letter
- • Approved indication (Nov 2008)
- • Approved indication (Mar 2009)
- • Approved indication (Mar 2010)Letter
- • Approved indication (Mar 2010)
- • Approved indication (Oct 2011)Label Letter
- • Approved indication (Oct 2012)
- • Approved indication (Mar 2015)
- • Approved indication (Aug 2016)Letter
- • Approved indication (Oct 2016)
- • Approved indication (Apr 2017)
- • Approved indication (Nov 2017)Letter
- • Approved indication (Nov 2017)
- • Approved indication (Nov 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Jan 2019)
- • Approved indication (Jan 2019)
- • Approved indication (Feb 2019)
- • Approved indication (Mar 2019)
- • Approved indication (Apr 2019)
- • Approved indication (May 2019)
- • Approved indication (Jul 2019)
- • Approved indication (Apr 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Mar 2022)
- • Approved indication (Sep 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Apr 2024)
- • Approved indication (Sep 2024)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
FLUOXETINE HYDROCHLORIDE FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.