TheraRadar
Data updated: Nov 8, 2026

FLUOXETINE HYDROCHLORIDE · STRIDES PHARMA INTL

Generic · see FLUOXETINE Trial Activity: Declining 13 active trials
CNS Approved 1987-12-29

FLUOXETINE HYDROCHLORIDE is FDA-approved to treat 6 conditions (same as PROZAC).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Eli Lilly and Company conducting 8 trials (11%)
64 indications explored (Broad Platform)
→ depression (14 trials)
→ major depressive disorder (12 trials)
→ anxiety disorders (3 trials)
48
Indications
--
Phase 3 Trials
38
Years on Market

Details

Status
Prescription
First Approved
1987-12-29
Routes
ORAL
Dosage Forms
CAPSULE, TABLET, SOLUTION, CAPSULE, DELAYED REL PELLETS

Companies

STRIDES PHARMA INTL Sun Pharma TWI PHARMS ADAPTIS Teva SOMERSET THERAPS LLC Aurobindo Pharma RISING CHARTWELL MOLECULAR TORRENT SCIEGEN PHARMS IVAX SUB TEVA PHARMS PHARM ASSOC LANNETT CO INC ALEMBIC PHARMS LTD ALEMBIC Lupin G AND W LABS INC BAJAJ FOSUN PHARMA CHARTWELL RX HERITAGE CADILA PHARMS LTD PHARMOBEDIENT Dr. Reddy's CARLSBAD CR DOUBLE CRANE Novartis PH HEALTH SOLIS PHARMS PHARMOBEDIENT CNSLTG SPECGX LLC STRIDES PHARMA NOVITIUM PHARMA UPSHER SMITH LABS ANI PHARMS NATCO PHARMA USA MICRO LABS PHARMAZONE ACCORD HLTHCARE LANDELA PHARM REGCON HOLDINGS
Active Ingredient: FLUOXETINE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE Approval History

2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1138 FDA actions from 2001 to 2026
Oct 2026 SUPPL
Label · Labeling
Jun 2026 SUPPL
Mfg · Manufacturing (CMC)
Jan 2026 SUPPL
Mfg · Manufacturing (CMC)

What FLUOXETINE HYDROCHLORIDE Treats

6 indications

FLUOXETINE HYDROCHLORIDE is approved for 6 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Major Depressive Disorder
  • Obsessive Compulsive Disorder
  • Bulimia Nervosa
  • Panic Disorder
  • Bipolar I Disorder
  • Treatment Resistant Depression

Same approved indications as PROZAC (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03448159 FLOW 18-6002 CTO #1465 Ph 2 completed Fluoxetine Opens Window to Improve Motor Recovery After Stroke
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

FLUOXETINE HYDROCHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

FLUOXETINE HYDROCHLORIDE is FDA-approved to treat 6 conditions — same approved indications as PROZAC.

Looking for the branded version?

FLUOXETINE

Full clinical data, patents, trials, and competitive landscape for fluoxetine hydrochloride.

See FLUOXETINE

Data Sources

FDA Approval: ANDA076922 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment