Data updated: Mar 10, 2026
CLEMASTINE FUMARATE
CLEMASTINE FUMARATE
Approved 1992-01-31
8
Indications
--
Phase 3 Trials
34
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1992-01-31
- Routes
- ORAL
- Dosage Forms
- SYRUP, TABLET
Companies
Teva PLD ACQUISITIONS LLC L PERRIGO CO GENUS ANI PHARMS OMNIVIUM PHARMS WOCKHARDT BIO AG NEW HEIGHTSRX Apotex
Active Ingredient: CLEMASTINE FUMARATE
Website: ↗
CLEMASTINE FUMARATE Approval History
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What CLEMASTINE FUMARATE Treats
8 FDA approvalsOriginally approved for its first indication in 1992 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Jan 1992)
- • Approved indication (Apr 1992)
- • Approved indication (Oct 1993)
- • Approved indication (Jun 1994)
- • Approved indication (Nov 1995)
- • Approved indication (Dec 1997)
- • Approved indication (Mar 1998)
- • Approved indication (Nov 2000)Letter
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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.
CLEMASTINE FUMARATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.