TheraRadar
Data updated: Mar 29, 2026

EZALLOR SPRINKLE

ROSUVASTATIN CALCIUM
Approved 2018-12-18
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
7
Years on Market

Details

Status
Discontinued
First Approved
2018-12-18
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Sun Pharma
Active Ingredient: ROSUVASTATIN CALCIUM

EZALLOR SPRINKLE Approval History

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What EZALLOR SPRINKLE Treats

2 FDA approvals

Originally approved for its first indication in 2018 . Covers 2 distinct patient populations.

  • Other (2)
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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.

EZALLOR SPRINKLE FDA Label Details

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EZALLOR SPRINKLE Patents & Exclusivity

Latest Patent: Feb 2036

Patents (16 active)

US10413543 Expires Feb 12, 2036
+ 6 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA208647 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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