Data updated: May 26, 2026
COGENTIN (benztropine mesylate)
CNS
Approved 1954-03-05
2
Indications
--
Phase 3 Trials
1
Priority Reviews
72
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1954-03-05
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
COGENTIN Approval History
1955
1956
1957
1958
1959
1960
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2026
Original
New Indication
New Form
Label Update
103 FDA actions from 1954 to 2015
Feb 2015 SUPPL
Mfg · Manufacturing (CMC)
Jun 2013 SUPPL
Mfg · Manufacturing (CMC)
Mar 2009 SUPPL
Label
Jul 1998 SUPPL
Mfg
Jul 1998 SUPPL
Mfg
Sep 1996 SUPPL
Label
Apr 1996 SUPPL Priority
Mfg
Jun 1994 SUPPL Priority
Mfg
Oct 1988 SUPPL
Mfg
Apr 1988 SUPPL Priority
Mfg
Jan 1988 SUPPL Priority
Mfg
Aug 1986 SUPPL Priority
Mfg
Jan 1986 SUPPL
Label
Sep 1984 SUPPL Priority
Mfg
Aug 1984 SUPPL Priority
Mfg
Sep 1982 SUPPL Priority
Mfg
Nov 1981 SUPPL
Mfg
Oct 1981 SUPPL
Mfg
Jun 1981 SUPPL Priority
Mfg
May 1981 SUPPL Priority
Mfg
May 1980 SUPPL Priority
Mfg
Oct 1979 SUPPL
Label
Apr 1979 SUPPL
Label
May 1977 SUPPL
Label
Mar 1977 SUPPL Priority
Mfg
Jan 1975 SUPPL
Label
Jul 1974 SUPPL Priority
Update
Dec 1959 ORIGINAL
New Form
What COGENTIN Treats
2 FDA approvalsOriginally approved for its first indication in 1954 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Mar 1954) PriorityLetter
- • Approved indication (Dec 1959)
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Pro Key Completed Trials
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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.
COGENTIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.