Data updated: Mar 10, 2026
LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE
Approved 1991-08-30
29
Indications
--
Phase 3 Trials
34
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 1991-08-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, SOLUTION
Companies
Aurobindo Pharma BIONPHARMA MARKSANS PHARMA ALPHARMA US PHARMS PERRIGO R AND D WOCKHARDT BIO AG L PERRIGO CO ZYDUS LIFESCIENCES Viatris WATSON LABS Teva RUBICON RESEARCH PERRIGO CONTRACT PHARMACAL ABLE LNK JUBILANT CADISTA OHM LABS ROXANE EDENBRIDGE PHARMS ALLIED ONESOURCE SPECIALTY PAI HOLDINGS CHARTWELL RX DURAMED PHARMS BARR
Active Ingredient: LOPERAMIDE HYDROCHLORIDE
Website: ↗
LOPERAMIDE HYDROCHLORIDE Approval History
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What LOPERAMIDE HYDROCHLORIDE Treats
29 FDA approvalsOriginally approved for its first indication in 1991 . Covers 29 distinct patient populations.
- Other (29)
Other
(29 approvals)- • Approved indication (Aug 1991)
- • Approved indication (Sep 1991)
- • Approved indication (Jan 1992)
- • Approved indication (Apr 1992)
- • Approved indication (Aug 1992)
- • Approved indication (Sep 1992)
- • Approved indication (Oct 1992)
- • Approved indication (Dec 1992)
- • Approved indication (Jul 1993)
- • Approved indication (Nov 1993)
- • Approved indication (Jun 1995)
- • Approved indication (Nov 1995)
- • Approved indication (Aug 1997)
- • Approved indication (Dec 1997)
- • Approved indication (Jan 2000)Label Letter
- • Approved indication (Jun 2003)
- • Approved indication (Aug 2005)Label Letter
- • Approved indication (May 2011)
- • Approved indication (Dec 2015)
- • Approved indication (Aug 2021)Letter
- • Approved indication (Oct 2021)
- • Approved indication (Oct 2021)
- • Approved indication (Jan 2023)
- • Approved indication (Mar 2023)
- • Approved indication (Jul 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Sep 2025) New
- • Approved indication (Nov 2025) New
- • Approved indication (Dec 2025) 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.
LOPERAMIDE 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.