Data updated: Mar 10, 2026
QUETIAPINE FUMARATE
QUETIAPINE FUMARATE
Approved 2012-03-27
22
Indications
--
Phase 3 Trials
13
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2012-03-27
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET
Companies
PH HEALTH ACCORD HLTHCARE JUBILANT GENERICS MACLEODS PHARMS LTD Lupin ALIGNSCIENCE PHARMA SCIEGEN PHARMS PHARMADAX INC RISING ALKEM LABS LTD UNICHEM Sun Pharma IPCA LABS LTD Teva Aurobindo Pharma CHARTWELL RX Hikma AMNEAL PHARMS TORRENT PHARMS LTD PRINSTON INC ALEMBIC PHARMOBEDIENT MEDICAP LABS HETERO LABS LTD V NOVAST LABS
Active Ingredient: QUETIAPINE FUMARATE
Website: ↗
QUETIAPINE FUMARATE Approval History
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What QUETIAPINE FUMARATE Treats
22 FDA approvalsOriginally approved for its first indication in 2012 . Covers 22 distinct patient populations.
- Other (22)
Other
(22 approvals)- • Approved indication (Mar 2012)Letter
- • Approved indication (Dec 2012)
- • Approved indication (Feb 2013)
- • Approved indication (Feb 2013)
- • Approved indication (Nov 2013)
- • Approved indication (Oct 2014)
- • Approved indication (Mar 2016)
- • Approved indication (May 2016)
- • Approved indication (Nov 2016)Label Letter
- • Approved indication (May 2017)Label Letter
- • Approved indication (May 2017)
- • Approved indication (Nov 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Sep 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Feb 2021)
- • Approved indication (Apr 2022)
- • Approved indication (Jun 2022)
- • Approved indication (Aug 2022)
- • Approved indication (Aug 2022)
- • Approved indication (May 2024)
- • Approved indication (Nov 2024)
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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.
QUETIAPINE FUMARATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.