Data updated: Mar 10, 2026
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
LOPERAMIDE HYDROCHLORIDE
Approved 2002-08-30
8
Indications
--
Phase 3 Trials
23
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2002-08-30
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, CHEWABLE
Companies
GRANULES BIONPHARMA PERRIGO PERRIGO R AND D Aurobindo Pharma HETERO LABS LTD V GUARDIAN DRUG Sun Pharma
Website: ↗
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE Approval History
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What LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE Treats
8 FDA approvalsOriginally approved for its first indication in 2002 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Aug 2002)
- • Approved indication (Sep 2006)Letter
- • Approved indication (Sep 2018)
- • Approved indication (Dec 2020)
- • Approved indication (May 2021)
- • Approved indication (Jun 2021)
- • Approved indication (Sep 2021)
- • Approved indication (Aug 2022)
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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.
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.