Data updated: Mar 10, 2026
DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE
Approved 1974-08-07
20
Indications
--
Phase 3 Trials
2
Priority Reviews
51
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1974-08-07
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE, INJECTABLE, LIPOSOMAL
Companies
HISUN PHARM HANGZHOU GLAND QILU PHARM HAINAN Pfizer Sun Pharma HLTHCARE Fresenius Kabi PHARMACHEMIE BV Teva AMNEAL Hikma SAGENT PHARMS Viatris PHARMOBEDIENT ALMAJECT
Active Ingredient: DOXORUBICIN HYDROCHLORIDE
Website: ↗
DOXORUBICIN HYDROCHLORIDE Approval History
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What DOXORUBICIN HYDROCHLORIDE Treats
20 FDA approvalsOriginally approved for its first indication in 1974 . Covers 20 distinct patient populations.
- Other (20)
Other
(20 approvals)- • Approved indication (Aug 1974) Priority
- • Approved indication (Dec 1987) Priority
- • Approved indication (Mar 1989)
- • Approved indication (May 1990)
- • Approved indication (Sep 1994)
- • Approved indication (Feb 1995)
- • Approved indication (Jul 1995)
- • Approved indication (Oct 1995)
- • Approved indication (May 2003)Label Letter
- • Approved indication (Oct 2011)
- • Approved indication (Feb 2012)
- • Approved indication (Feb 2012)
- • Approved indication (Jul 2012)
- • Approved indication (Nov 2012)
- • Approved indication (Mar 2013)
- • Approved indication (Jun 2014)
- • Approved indication (Feb 2017)
- • Approved indication (Aug 2017)
- • Approved indication (May 2019)
- • Approved indication (Feb 2026) 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.
DOXORUBICIN 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.