Data updated: Mar 10, 2026
DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE
Approved 1974-09-30
34
Indications
--
Phase 3 Trials
51
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1974-09-30
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE, CAPSULE, SYRUP
Companies
WATSON LABS Sun Pharma SLATE RUN PHARMA RISING Dr. Reddy's Aurobindo Pharma RENEW PHARMS FOSUN PHARMA COREPHARMA PIONEER PHARMS SOMERSET THERAPS LLC NOVITIUM PHARMA ANNORA PHARMA ALPHARMA US PHARMS LANNETT PRAXGEN PHARMS Hikma RUBICON RESEARCH PH HEALTH Fresenius Kabi TWI PHARMS BIONPHARMA AM REGENT PRINSTON INC NEXUS
Active Ingredient: DICYCLOMINE HYDROCHLORIDE
Website: ↗
DICYCLOMINE HYDROCHLORIDE Approval History
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What DICYCLOMINE HYDROCHLORIDE Treats
34 FDA approvalsOriginally approved for its first indication in 1974 . Covers 34 distinct patient populations.
- Other (34)
Other
(34 approvals)- • Approved indication (Sep 1974)
- • Approved indication (May 1975)
- • Approved indication (Jun 1975)
- • Approved indication (Jul 1976)
- • Approved indication (Aug 1976)
- • Approved indication (Feb 1986)
- • Approved indication (Oct 1996)
- • Approved indication (Feb 1997)
- • Approved indication (Feb 1999)Label Letter
- • Approved indication (Sep 1999)Letter
- • Approved indication (Mar 2005)
- • Approved indication (Feb 2017)
- • Approved indication (May 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Feb 2019)
- • Approved indication (Feb 2019)
- • Approved indication (Apr 2019)
- • Approved indication (May 2020)Letter
- • Approved indication (Apr 2021)
- • Approved indication (Nov 2022)
- • Approved indication (Dec 2022)
- • Approved indication (Dec 2022)
- • Approved indication (Mar 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Aug 2023)
- • Approved indication (Aug 2023)
- • Approved indication (May 2024)
- • Approved indication (Jul 2024)
- • Approved indication (Nov 2024)
- • Approved indication (Nov 2024)
- • Approved indication (Jun 2025) New
- • Approved indication (Jun 2025) New
🔬
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.
DICYCLOMINE 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.