TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

DYLOJECT

DICLOFENAC SODIUM
Approved 2014-12-23
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Discontinued
First Approved
2014-12-23
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

JAVELIN PHARMS INC
Active Ingredient: DICLOFENAC SODIUM

DYLOJECT Approval History

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What DYLOJECT Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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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

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.

DYLOJECT FDA Label Details

Pro

DYLOJECT Patents & Exclusivity

Latest Patent: Mar 2027

Patents (1 active)

US8946292 Expires Mar 22, 2027
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA022396 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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