TheraRadar
Data updated: Jun 28, 2026

QUALAQUIN (quinine sulfate) · Sun Pharma

Infectious Disease Approved 2005-08-12

QUALAQUIN is FDA-approved to treat 1 condition (same as QUININE SULFATE).

1
Indication
--
Phase 3 Trials
20
Years on Market

Details

Status
Discontinued
First Approved
2005-08-12
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Active Ingredient: QUININE SULFATE

QUALAQUIN Approval History

2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
14 FDA actions from 2005 to 2019
Jun 2019 SUPPL
Label · Labeling
Jul 2014 SUPPL
Label · Labeling
Apr 2013 SUPPL
Label · Labeling

What QUALAQUIN Treats

1 indications

QUALAQUIN is approved for 1 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Malaria

Same approved indications as QUININE SULFATE (same active ingredient).

Source: FDA Label

Sun Pharma's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT02630472 QSIND results posted 821731 Ph 1, Ph 2 terminated Topical Irrigation Therapy for CRS
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

QUALAQUIN FDA Label Details

Indications & Usage

FDA Label (PDF)

QUALAQUIN is FDA-approved to treat 1 condition — same approved indications as QUININE SULFATE.

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Data Sources

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