Data updated: Mar 10, 2026
BETHANECHOL CHLORIDE
BETHANECHOL CHLORIDE
Approved 1974-11-11
20
Indications
--
Phase 3 Trials
51
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1974-11-11
- Routes
- ORAL, Injection
- Dosage Forms
- TABLET, Injectable
Companies
WATSON LABS ASCOT Teva UPSHER SMITH LABS AMNEAL PHARM Novartis QUAD PHARMS ABLE WOCKHARDT LANNETT IMPAX LABS CHARTWELL RX HERITAGE PHARMA IVAX SUB TEVA PHARMS Sun Pharma LANNETT CO INC
Active Ingredient: BETHANECHOL CHLORIDE
Website: ↗
BETHANECHOL CHLORIDE Approval History
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What BETHANECHOL CHLORIDE Treats
20 FDA approvalsOriginally approved for its first indication in 1974 . Covers 20 distinct patient populations.
- Other (20)
Other
(20 approvals)- • Approved indication (Nov 1974)
- • Approved indication (Nov 1974)
- • Approved indication (Jan 1975)
- • Approved indication (Jul 1975)
- • Approved indication (Dec 1975)
- • Approved indication (Jun 1976)
- • Approved indication (Jul 1976)
- • Approved indication (Aug 1977)
- • Approved indication (Jul 1981)
- • Approved indication (Sep 1994)
- • Approved indication (Sep 2003)
- • Approved indication (Jul 2004)
- • Approved indication (Oct 2004)
- • Approved indication (Jun 2005)
- • Approved indication (Nov 2006)
- • Approved indication (Oct 2007)
- • Approved indication (Nov 2007)
- • Approved indication (Mar 2008)
- • Approved indication (Apr 2009)
- • Approved indication (May 2010)
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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.
BETHANECHOL CHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.