Data updated: Mar 10, 2026
MELPHALAN HYDROCHLORIDE
MELPHALAN HYDROCHLORIDE
Approved 2009-06-09
18
Indications
--
Phase 3 Trials
16
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2009-06-09
- Routes
- INTRAVENOUS, INJECTION
- Dosage Forms
- POWDER, INJECTABLE
Companies
Teva HETERO LABS Dr. Reddy's SAGENT PHARMS INC ALMAJECT GLAND Viatris AVET LIFESCIENCES ARTHUR GRP NOVAST LABS Fresenius Kabi Hikma PH HEALTH USWM MEITHEAL BPI LABS
Active Ingredient: MELPHALAN HYDROCHLORIDE
Website: ↗
MELPHALAN HYDROCHLORIDE Approval History
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What MELPHALAN HYDROCHLORIDE Treats
18 FDA approvalsOriginally approved for its first indication in 2009 . Covers 18 distinct patient populations.
- Other (18)
Other
(18 approvals)- • Approved indication (Jun 2009)Letter
- • Approved indication (Oct 2009)
- • Approved indication (Oct 2010)
- • Approved indication (Aug 2016)Letter
- • Approved indication (Dec 2016)
- • Approved indication (Feb 2017)Letter
- • Approved indication (Dec 2017)Label Letter
- • Approved indication (Dec 2017)Letter
- • Approved indication (May 2019)
- • Approved indication (May 2019)
- • Approved indication (May 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Feb 2020)
- • Approved indication (Mar 2020)Letter
- • Approved indication (May 2020)
- • Approved indication (May 2021)
- • Approved indication (May 2024)
- • Approved indication (Oct 2024)
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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.
MELPHALAN 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.