Data updated: Mar 10, 2026
GALANTAMINE HYDROBROMIDE
GALANTAMINE HYDROBROMIDE
Approved 2008-08-28
18
Indications
--
Phase 3 Trials
17
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2008-08-28
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, EXTENDED RELEASE, SOLUTION
Companies
Apotex IMPAX LABS CHARTWELL RX YABAO PHARM WATSON LABS HERITAGE PHARMA ZYDUS PHARMS USA INC RANBAXY Novartis Teva Hikma Aurobindo Pharma Sun Pharma SENORES PHARMS PHARMOBEDIENT Viatris
Active Ingredient: GALANTAMINE HYDROBROMIDE
Website: ↗
GALANTAMINE HYDROBROMIDE Approval History
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What GALANTAMINE HYDROBROMIDE Treats
18 FDA approvalsOriginally approved for its first indication in 2008 . Covers 18 distinct patient populations.
- Other (18)
Other
(18 approvals)- • Approved indication (Aug 2008)Label Letter
- • Approved indication (Sep 2008)
- • Approved indication (Sep 2008)Letter
- • Approved indication (Dec 2008)
- • Approved indication (Jan 2009)Label Letter
- • Approved indication (Feb 2009)
- • Approved indication (Feb 2009)
- • Approved indication (May 2009)
- • Approved indication (May 2009)
- • Approved indication (Jun 2009)
- • Approved indication (Jul 2009)
- • Approved indication (Sep 2009)
- • Approved indication (Jan 2011)
- • Approved indication (Feb 2011)
- • Approved indication (Feb 2011)
- • Approved indication (Mar 2011)
- • Approved indication (Sep 2011)
- • Approved indication (Aug 2016)
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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.
GALANTAMINE HYDROBROMIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.