Data updated: Mar 10, 2026
CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE
Approved 1972-03-16
43
Indications
--
Phase 3 Trials
53
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1972-03-16
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, SYRUP, INJECTABLE, CONCENTRATE
Companies
CHARTWELL RX UPSHER SMITH LABS LEDERLE Hikma VANGARD PUREPAC PHARM ALPHARMA US PHARMS MARSAM PHARMS LLC ZYDUS PHARMS KV PHARM Teva WOCKHARDT SOMERSET THERAPS LLC GENUS ASPIRO Dr. Reddy's ABBOTT AMNEAL PHARMS CO Lupin RUBICON PHARM ASSOC ABRAXIS PHARM WATSON LABS ALEMBIC IVAX SUB TEVA PHARMS GLENMARK PHARMS LTD ZAMEER PHARMS MSN PVT FORM ZYDUS LIFESCIENCES GLAND CYCLE EUGIA PHARMA Sun Pharma Aurobindo Pharma DEVA HLDING Pfizer LANNETT CO INC THINQ PHARM-CRO PVT
Active Ingredient: CHLORPROMAZINE HYDROCHLORIDE
Website: ↗
CHLORPROMAZINE HYDROCHLORIDE Approval History
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What CHLORPROMAZINE HYDROCHLORIDE Treats
43 FDA approvalsOriginally approved for its first indication in 1972 . Covers 43 distinct patient populations.
- Other (43)
Other
(43 approvals)- • Approved indication (Mar 1972)
- • Approved indication (Jan 1973)
- • Approved indication (Feb 1974)
- • Approved indication (May 1974)
- • Approved indication (Jul 1974)
- • Approved indication (Jul 1974)
- • Approved indication (Jul 1977)
- • Approved indication (Dec 1977)
- • Approved indication (Feb 1978)
- • Approved indication (Nov 1979)
- • Approved indication (Nov 1979)
- • Approved indication (Nov 1980)
- • Approved indication (Nov 1980)
- • Approved indication (Dec 1980)
- • Approved indication (Feb 1981)
- • Approved indication (Dec 1981)
- • Approved indication (Jul 1982)
- • Approved indication (Aug 1982)
- • Approved indication (Sep 1982)
- • Approved indication (Apr 1988)
- • Approved indication (Jan 1999)Letter
- • Approved indication (Dec 1999)Letter
- • Approved indication (Sep 2018)
- • Approved indication (Jan 2020)
- • Approved indication (Jul 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Jan 2021)
- • Approved indication (Mar 2021)Letter
- • Approved indication (Jun 2021)Letter
- • Approved indication (Oct 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Jan 2022)
- • Approved indication (Jul 2023)
- • Approved indication (Jul 2023)
- • Approved indication (Mar 2024)
- • Approved indication (Sep 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Nov 2024)
- • Approved indication (Dec 2024)
- • Approved indication (Apr 2025) New
- • Approved indication (Oct 2025) New
- • Approved indication (Jan 2026) 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.
CHLORPROMAZINE 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.