Data updated: Mar 10, 2026
FLUPHENAZINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE
Approved 1987-04-16
26
Indications
--
Phase 3 Trials
38
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1987-04-16
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, ELIXIR, CONCENTRATE, INJECTABLE
Companies
WATSON LABS ZYDUS LIFESCIENCES ZAMEER PHARMS MSN LANNETT GLENMARK PHARMS LTD ANI PHARMS AMNEAL NOVITIUM PHARMA UPSHER SMITH LABS TWI PHARMS Novartis PRASCO Dr. Reddy's BRECKENRIDGE Aurobindo Pharma Fresenius Kabi AJANTA PHARMA LTD LANNETT CO INC TARO Apotex TORRENT ALEMBIC RISING PHARM ASSOC HETERO LABS LTD III
Active Ingredient: FLUPHENAZINE HYDROCHLORIDE
Website: ↗
FLUPHENAZINE HYDROCHLORIDE Approval History
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What FLUPHENAZINE HYDROCHLORIDE Treats
26 FDA approvalsOriginally approved for its first indication in 1987 . Covers 26 distinct patient populations.
- Other (26)
Other
(26 approvals)- • Approved indication (Apr 1987)
- • Approved indication (Oct 1987)
- • Approved indication (Aug 1988)
- • Approved indication (Aug 1988)
- • Approved indication (Aug 1991)
- • Approved indication (Apr 1993)
- • Approved indication (Aug 1996)
- • Approved indication (Sep 1996)
- • Approved indication (Jul 2020)
- • Approved indication (Jan 2021)
- • Approved indication (Mar 2021)
- • Approved indication (May 2021)
- • Approved indication (Oct 2021)
- • Approved indication (Apr 2022)
- • Approved indication (Apr 2022)
- • Approved indication (Jul 2022)
- • Approved indication (Oct 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Jan 2023)
- • Approved indication (Aug 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Nov 2023)
- • Approved indication (Jan 2024)
- • Approved indication (Jun 2024)
- • Approved indication (Jul 2024)
- • Approved indication (Nov 2025) New
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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.
FLUPHENAZINE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.