TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

BENDAMUSTINE HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE
Approved 2022-12-07
Jump to: Indications Approvals Trials Competitors Safety Patents
7
Indications
--
Phase 3 Trials
3
Years on Market

Details

Status
None (Tentative Approval)
First Approved
2022-12-07
Routes
IV (INFUSION), INTRAVENOUS
Dosage Forms
POWDER, SOLUTION

Companies

GLENMARK PHARMS LTD EUGIA PHARMA Dr. Reddy's BRECKENRIDGE NANG KUANG PHARM CO Pfizer Fresenius Kabi Baxter ACCORD HLTHCARE CELERITY PHARMS Apotex PHARMOBEDIENT MEITHEAL
Active Ingredient: BENDAMUSTINE HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE Approval History

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What BENDAMUSTINE HYDROCHLORIDE Treats

7 FDA approvals

Originally approved for its first indication in 2022 . Covers 7 distinct patient populations.

  • Other (7)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

BENDAMUSTINE HYDROCHLORIDE FDA Label Details

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Data Sources

FDA Approval: ANDA204771 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.