TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

TOPOTECAN HYDROCHLORIDE

TOPOTECAN HYDROCHLORIDE
Approved 2010-11-29
Jump to: Indications Approvals Trials Competitors Safety Patents
15
Indications
--
Phase 3 Trials
15
Years on Market

Details

Status
Discontinued
First Approved
2010-11-29
Routes
INJECTION, INTRAVENOUS
Dosage Forms
INJECTABLE, SOLUTION

Companies

Fresenius Kabi ACCORD HLTHCARE INGENUS PHARMS LLC SAGENT PHARMS Teva RISING TEYRO LABS Pfizer Dr. Reddy's MEITHEAL DASH PHARMS Sun Pharma
Active Ingredient: TOPOTECAN HYDROCHLORIDE

TOPOTECAN HYDROCHLORIDE Approval History

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What TOPOTECAN HYDROCHLORIDE Treats

15 FDA approvals

Originally approved for its first indication in 2010 . Covers 15 distinct patient populations.

  • Other (15)
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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.

TOPOTECAN HYDROCHLORIDE FDA Label Details

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Data Sources

FDA Approval: ANDA091376 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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