Data updated: Mar 10, 2026
RISPERIDONE
RISPERIDONE
Approved 2008-06-30
42
Indications
--
Phase 3 Trials
17
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2008-06-30
- Routes
- ORAL, INTRAMUSCULAR
- Dosage Forms
- TABLET, SOLUTION, TABLET, ORALLY DISINTEGRATING, POWDER
Companies
DASH PHARMS PRECISION DOSE ZYDUS PHARMS USA TRIS PHARMA INC AMNEAL PHARMS Sun Pharma Hikma NOVITIUM PHARMA JUBILANT GENERICS AMNEAL CHARTWELL MOLECULAR RATIOPHARM RENATA RANBAXY PRINSTON INC PH HEALTH HERITAGE PHARMA AVET ZYDUS PHARMS USA INC WOCKHARDT BIO AG LANNETT CO INC ANI PHARMS Teva PHARM ASSOC Novartis SYNTHON PHARMS TORRENT PHARMS Dr. Reddy's WATSON LABS RISING NANOMI Aurobindo Pharma APOZEAL PHARMS IPCA LABS LTD AJANTA PHARMA LTD CHARTWELL RX SENORES PHARMS Apotex JUBILANT CADISTA SUN PHARMA CANADA
Active Ingredient: RISPERIDONE
Website: ↗
RISPERIDONE Approval History
Loading approval history...
What RISPERIDONE Treats
42 FDA approvalsOriginally approved for its first indication in 2008 . Covers 42 distinct patient populations.
- Other (42)
Other
(42 approvals)- • Approved indication (Jun 2008)Label Letter
- • Approved indication (Sep 2008)
- • Approved indication (Oct 2008)
- • Approved indication (Oct 2008)
- • Approved indication (Oct 2008)
- • Approved indication (Oct 2008)
- • Approved indication (Oct 2008)
- • Approved indication (Dec 2008)
- • Approved indication (Dec 2008)
- • Approved indication (Jan 2009)
- • Approved indication (Feb 2009)Label
- • Approved indication (Mar 2009)
- • Approved indication (Apr 2009)
- • Approved indication (May 2009)
- • Approved indication (May 2009)
- • Approved indication (Jun 2009)
- • Approved indication (Jul 2009)
- • Approved indication (Sep 2009)
- • Approved indication (Oct 2009)
- • Approved indication (Oct 2009)
- • Approved indication (Oct 2009)
- • Approved indication (Dec 2009)
- • Approved indication (Jun 2010)
- • Approved indication (Jun 2010)
- • Approved indication (Aug 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Feb 2011)
- • Approved indication (Mar 2011)
- • Approved indication (Apr 2011)
- • Approved indication (May 2011)
- • Approved indication (May 2011)
- • Approved indication (Aug 2011)
- • Approved indication (Nov 2011)
- • Approved indication (Nov 2011)
- • Approved indication (Mar 2012)
- • Approved indication (Dec 2012)
- • Approved indication (Apr 2013)
- • Approved indication (Mar 2014)
- • Approved indication (Jan 2015)
- • Approved indication (Dec 2023)
- • Approved indication (Jun 2024)
- • Approved indication (Sep 2025) New
🔬
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.
RISPERIDONE 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.