TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ARGATROBAN IN SODIUM CHLORIDE

ARGATROBAN
Approved 2011-05-09
Jump to: Indications Approvals Trials Competitors Safety Patents
5
Indications
--
Phase 3 Trials
14
Years on Market

Details

Status
Discontinued
First Approved
2011-05-09
Routes
INTRAVENOUS
Dosage Forms
INJECTABLE, SOLUTION

Companies

Cipla GLAND EUGIA PHARMA SPECLTS PLANO PHARMS ACCORD HLTHCARE
Active Ingredient: ARGATROBAN

ARGATROBAN IN SODIUM CHLORIDE Approval History

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What ARGATROBAN IN SODIUM CHLORIDE Treats

5 FDA approvals

Originally approved for its first indication in 2011 . Covers 5 distinct patient populations.

  • Other (5)
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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.

ARGATROBAN IN SODIUM CHLORIDE FDA Label Details

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ARGATROBAN IN SODIUM CHLORIDE Patents & Exclusivity

Latest Patent: Sep 2027

Patents (2 active)

US7687516 Expires Sep 26, 2027
US7589106 Expires Sep 26, 2027
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA022434 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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