Data updated: Mar 10, 2026
AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE
Approved 1976-11-16
42
Indications
--
Phase 3 Trials
49
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1976-11-16
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
Companies
WATSON LABS ROXANE Viatris Teva LEDERLE COPLEY PHARM PAR PHARM SUPERPHARM PLIVA UCB INC VANGARD PUREPAC PHARM AM THERAP MUTUAL PHARM HALSEY ZYDUS PHARMS RISING Novartis AIPING PHARM INC UNICHEM MANKIND PHARMA UNIQUE PHARM PH HEALTH ANI PHARMS USL PHARMA BRECKENRIDGE RUBICON RESEARCH Aurobindo Pharma Sun Pharma ACCORD HLTHCARE ANI PHARMS INC Hikma
Active Ingredient: AMITRIPTYLINE HYDROCHLORIDE
Website: ↗
AMITRIPTYLINE HYDROCHLORIDE Approval History
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What AMITRIPTYLINE HYDROCHLORIDE Treats
42 FDA approvalsOriginally approved for its first indication in 1976 . Covers 42 distinct patient populations.
- Other (42)
Other
(42 approvals)- • Approved indication (Nov 1976)
- • Approved indication (Nov 1976)
- • Approved indication (May 1977)
- • Approved indication (Jun 1977)
- • Approved indication (Jul 1977)
- • Approved indication (Jul 1977)
- • Approved indication (Aug 1977)
- • Approved indication (Sep 1977)
- • Approved indication (Oct 1977)
- • Approved indication (Oct 1977)
- • Approved indication (Nov 1977)
- • Approved indication (Nov 1977)
- • Approved indication (Jan 1978)
- • Approved indication (Apr 1978)
- • Approved indication (Apr 1978)
- • Approved indication (May 1978)
- • Approved indication (Aug 1978)
- • Approved indication (Aug 1978)
- • Approved indication (Sep 1978)
- • Approved indication (Sep 1978)
- • Approved indication (Nov 1981)
- • Approved indication (Feb 1982)
- • Approved indication (Feb 1982)
- • Approved indication (Feb 1982)
- • Approved indication (Feb 1982)
- • Approved indication (May 1983)
- • Approved indication (Mar 1984)
- • Approved indication (Sep 1984)
- • Approved indication (Sep 1984)
- • Approved indication (Feb 1987)
- • Approved indication (Jul 1987)
- • Approved indication (Sep 1997)
- • Approved indication (Jun 2008)
- • Approved indication (Jun 2014)
- • Approved indication (Oct 2017)
- • Approved indication (Apr 2020)
- • Approved indication (Feb 2021)
- • Approved indication (May 2021)
- • Approved indication (Jun 2022)
- • Approved indication (May 2023)
- • Approved indication (May 2023)
- • Approved indication (Jun 2025) New
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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.
AMITRIPTYLINE 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.