Data updated: Mar 10, 2026
OLANZAPINE
OLANZAPINE
Approved 2011-10-24
33
Indications
--
Phase 3 Trials
14
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2011-10-24
- Routes
- ORAL, INTRAMUSCULAR
- Dosage Forms
- TABLET, TABLET, ORALLY DISINTEGRATING, POWDER
Companies
IVAX PHARMS INC PHARMOBEDIENT ALKEM LABS LTD CADILA PHARMS LTD Dr. Reddy's NATCO PHARMA Sun Pharma TORRENT PHARMS LTD Novartis Aurobindo Pharma MACLEODS PHARMS LTD Apotex TORRENT Hikma SUNSHINE HEC PHARM Teva STRIDES PHARMA INTL ZYDUS PHARMS AJANTA PHARMA LTD EUGIA PHARMA OMNIVIUM PHARMS HISUN PHARM HANGZHOU JIANGSU HANSOH PHARM UBI QILU AM REGENT CHARTWELL MOLECULAR ORBION PHARMS ASPIRO JUBILANT GENERICS ROXANE INDOCO
Active Ingredient: OLANZAPINE
Website: ↗
OLANZAPINE Approval History
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What OLANZAPINE Treats
33 FDA approvalsOriginally approved for its first indication in 2011 . Covers 33 distinct patient populations.
- Other (33)
Other
(33 approvals)- • Approved indication (Oct 2011)
- • Approved indication (Oct 2011)
- • Approved indication (Jan 2012)Letter
- • Approved indication (Feb 2012)
- • Approved indication (Mar 2012)
- • Approved indication (Apr 2012)
- • Approved indication (Sep 2012)
- • Approved indication (May 2014)
- • Approved indication (May 2014)
- • Approved indication (Aug 2014)
- • Approved indication (Feb 2015)
- • Approved indication (Mar 2015)
- • Approved indication (Apr 2015)
- • Approved indication (Oct 2015)
- • Approved indication (Jan 2016)
- • Approved indication (Mar 2016)
- • Approved indication (Mar 2016)
- • Approved indication (Aug 2016)
- • Approved indication (May 2017)
- • Approved indication (Jun 2017)
- • Approved indication (Jul 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Sep 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Jul 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Feb 2023)
- • Approved indication (Mar 2023)
- • Approved indication (Mar 2023)
- • Approved indication (May 2025) New
- • Approved indication (Jun 2025) New
- • Approved indication (Jan 2026) New
🔬
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.
OLANZAPINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.