Data updated: Mar 10, 2026
PROCHLORPERAZINE EDISYLATE
PROCHLORPERAZINE EDISYLATE
Approved 1979-07-05
20
Indications
--
Phase 3 Trials
46
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1979-07-05
- Routes
- INJECTION, ORAL, Injection
- Dosage Forms
- INJECTABLE, SYRUP, Injectable, CONCENTRATE
Companies
Teva Pfizer MORTON GROVE CAPLIN Hikma QUAD PHARMS AMNEAL ALPHARMA US PHARMS SOMERSET THERAPS LLC VIWIT PHARM EUGIA PHARMA WATSON LABS AVET LIFESCIENCES NEXUS Viatris SMITH AND NEPHEW GLAND MARSAM PHARMS LLC SAGENT
Active Ingredient: PROCHLORPERAZINE EDISYLATE
Website: ↗
PROCHLORPERAZINE EDISYLATE Approval History
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What PROCHLORPERAZINE EDISYLATE Treats
20 FDA approvalsOriginally approved for its first indication in 1979 . Covers 20 distinct patient populations.
- Other (20)
Other
(20 approvals)- • Approved indication (Jul 1979)
- • Approved indication (Sep 1982)
- • Approved indication (Jul 1987)
- • Approved indication (Apr 1988)
- • Approved indication (May 1988)
- • Approved indication (Dec 1988)
- • Approved indication (Aug 1989)
- • Approved indication (Mar 1997)
- • Approved indication (May 2003)
- • Approved indication (May 2004)
- • Approved indication (Oct 2013)
- • Approved indication (Oct 2018)
- • Approved indication (Feb 2019)
- • Approved indication (Apr 2021)
- • Approved indication (Sep 2021)
- • Approved indication (Sep 2021)
- • Approved indication (Jul 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Sep 2024)
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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.
PROCHLORPERAZINE EDISYLATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.