Data updated: May 26, 2026
TOFRANIL (imipramine hydrochloride)
CNS
Approved 1959-10-02
2
Indications
--
Phase 3 Trials
66
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1959-10-02
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET
TOFRANIL Approval History
1960
1961
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Original
New Indication
New Form
Label Update
35 FDA actions from 1959 to 2017
Jun 2017 SUPPL
Label · Labeling
Jun 2007 SUPPL
Label
Sep 2005 SUPPL
Label
Jun 2005 SUPPL
Label
Aug 2004 SUPPL
Label
Jun 2002 SUPPL
Mfg
Sep 2000 SUPPL
Mfg
Jul 1999 SUPPL
Mfg
Sep 1998 SUPPL
Mfg
Sep 1998 SUPPL
Label
Sep 1997 SUPPL
Mfg
Dec 1994 SUPPL
Label
Feb 1993 SUPPL
Mfg
Feb 1993 SUPPL
Label
Dec 1992 SUPPL
Mfg
Dec 1992 SUPPL
Mfg
Dec 1992 SUPPL
Label
Oct 1986 SUPPL
Mfg
Jul 1986 SUPPL
Mfg
Nov 1985 SUPPL
Mfg
May 1985 SUPPL
Mfg
Apr 1985 SUPPL
Label
Oct 1984 SUPPL
Label
May 1984 ORIGINAL
Update
May 1984 SUPPL
Label
Jun 1983 SUPPL
Mfg
Mar 1981 SUPPL
Mfg
Mar 1980 SUPPL
Mfg
Dec 1978 SUPPL
Label
Oct 1959 ORIGINAL
New Form
What TOFRANIL Treats
2 FDA approvalsOriginally approved for its first indication in 1959 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Oct 1959)
- • Approved indication (May 1984)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04863950 | CTMS# 20-0148 | Ph 2 | recruiting | Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma |
🔬
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.
TOFRANIL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.