TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

HYDROXYCHLOROQUINE SULFATE

HYDROXYCHLOROQUINE SULFATE
Approved 1994-09-30
Jump to: Indications Approvals Trials Competitors Safety Patents
14
Indications
--
Phase 3 Trials
31
Years on Market

Details

Status
Discontinued
First Approved
1994-09-30
Routes
ORAL
Dosage Forms
TABLET

Companies

WATSON LABS ZYDUS PHARMS USA INC Aurobindo Pharma CHARTWELL RX CREEKWOOD PHARMS Teva Novartis AMNEAL PHARMS CO ACCORD HLTHCARE Hikma SENORES PHARMS APPCO IPCA LABS LTD ALKALOIDA ZRT LAURUS
Active Ingredient: HYDROXYCHLOROQUINE SULFATE

HYDROXYCHLOROQUINE SULFATE Approval History

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What HYDROXYCHLOROQUINE SULFATE Treats

14 FDA approvals

Originally approved for its first indication in 1994 . Covers 14 distinct patient populations.

  • Other (14)
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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.

HYDROXYCHLOROQUINE SULFATE FDA Label Details

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Data Sources

FDA Approval: ANDA040133 → Trials: ClinicalTrials.gov →

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