Data updated: Mar 10, 2026
LURASIDONE HYDROCHLORIDE
LURASIDONE HYDROCHLORIDE
Approved 2019-01-03
16
Indications
--
Phase 3 Trials
7
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2019-01-03
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
PAR PHARM INC AMNEAL PHARMS CO ACCORD HLTHCARE ALKEM LABS LTD Teva MACLEODS PHARMS LTD ALEMBIC Aurobindo Pharma Dr. Reddy's Sun Pharma ANNORA PHARMA WATSON LABS TEVA CHARTWELL RX INVAGEN PHARMS JUBILANT GENERICS ZYDUS PHARMS TORRENT Lupin MSN HERITAGE PHARMA AVET
Active Ingredient: LURASIDONE HYDROCHLORIDE
Website: ↗
LURASIDONE HYDROCHLORIDE Approval History
Loading approval history...
What LURASIDONE HYDROCHLORIDE Treats
16 FDA approvalsOriginally approved for its first indication in 2019 . Covers 16 distinct patient populations.
- Other (16)
Other
(16 approvals)- • Approved indication (Jan 2019)Letter
- • Approved indication (Jan 2019)
- • Approved indication (Mar 2019)Letter
- • Approved indication (May 2019)
- • Approved indication (Sep 2019)Letter
- • Approved indication (Dec 2020)Letter
- • Approved indication (Feb 2021)
- • Approved indication (May 2021)
- • Approved indication (Aug 2021)
- • Approved indication (Sep 2022)
- • Approved indication (Dec 2022)Letter
- • Approved indication (Mar 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Aug 2024)
- • Approved indication (Dec 2024)
- • Approved indication (Jan 2025)
🔬
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.
LURASIDONE 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.