COGENTIN (benztropine mesylate) · Merck
COGENTIN is FDA-approved to treat 2 conditions (same as BENZTROPINE MESYLATE).
Details
- Status
- Discontinued
- First Approved
- 1954-03-05
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
COGENTIN Approval History
What COGENTIN Treats
2 indicationsCOGENTIN is approved for 2 conditions since its original approval in 1954. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Parkinsonism
- Extrapyramidal Disorder
Same approved indications as BENZTROPINE MESYLATE (same active ingredient).
Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
COGENTIN FDA Label Details
Indications & Usage
FDA Label (PDF)COGENTIN is FDA-approved to treat 2 conditions — same approved indications as BENZTROPINE MESYLATE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.