Data updated: Mar 10, 2026
CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE
Approved 1979-04-23
30
Indications
--
Phase 3 Trials
46
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1979-04-23
- Routes
- ORAL
- Dosage Forms
- TABLET, SYRUP
Companies
WATSON LABS VITARINE PLIVA STRIDES PHARMA INTL SUPERPHARM Viatris KV PHARM ASCOT PATRIN INGENUS PHARMS LLC ST JOHN PHARM QUAGEN CHARTWELL RX AM THERAP HALSEY PHARM ASSOC MOUNTAIN Teva MORTON GROVE DURAMED PHARMS BARR NASKA TRIS PHARMA INC KENTON RISING HERITAGE PHARMA CHARTWELL MOLECULAR REGCON HOLDINGS ZYDUS PHARMS MD PHARM PIONEER PHARMS APPCO
Active Ingredient: CYPROHEPTADINE HYDROCHLORIDE
Website: ↗
CYPROHEPTADINE HYDROCHLORIDE Approval History
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What CYPROHEPTADINE HYDROCHLORIDE Treats
30 FDA approvalsOriginally approved for its first indication in 1979 . Covers 30 distinct patient populations.
- Other (30)
Other
(30 approvals)- • Approved indication (Apr 1979)
- • Approved indication (Jan 1980)
- • Approved indication (Apr 1980)
- • Approved indication (Oct 1980)
- • Approved indication (Feb 1981)
- • Approved indication (May 1981)
- • Approved indication (Jul 1981)
- • Approved indication (Sep 1981)
- • Approved indication (May 1983)
- • Approved indication (Jul 1983)
- • Approved indication (Oct 1983)
- • Approved indication (Jul 1986)
- • Approved indication (Dec 1987)
- • Approved indication (Sep 2003)
- • Approved indication (May 2006)
- • Approved indication (Jun 2006)Letter
- • Approved indication (Mar 2013)
- • Approved indication (Sep 2015)
- • Approved indication (Nov 2016)
- • Approved indication (Dec 2016)
- • Approved indication (Dec 2016)
- • Approved indication (Jan 2017)
- • Approved indication (May 2017)
- • Approved indication (Jul 2017)
- • Approved indication (Apr 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Apr 2019)
- • Approved indication (May 2019)
- • Approved indication (Feb 2021)
- • Approved indication (Dec 2021)
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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.
CYPROHEPTADINE 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.