What is LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER used for?

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER is an FDA-approved medication. See full prescribing information for approved uses.

Is LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER FDA approved?

Yes, LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER is FDA approved (first approved 1996-12-20) and manufactured by Johnson & Johnson.

Who makes LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER?

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER is manufactured by Johnson & Johnson.

Data updated: Mar 10, 2026

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

LEVOFLOXACIN

Approved 1996-12-20

Jump to: Indications Approvals Trials Competitors Safety Patents

Indications

Phase 3 Trials

Priority Reviews

Years on Market

Details

Status: Discontinued
First Approved: 1996-12-20
Routes: INJECTION
Dosage Forms: INJECTABLE

Companies

Johnson & Johnson

Active Ingredient: LEVOFLOXACIN

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER Approval History

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What LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER Treats

14 FDA approvals

Originally approved for its first indication in 1996 . 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

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.

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER FDA Label Details

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Data Sources

FDA Approval: NDA020635 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Details

Companies

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER Approval History

What LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER Treats

Other

Active Pipeline

Key Completed Trials

Trial Timeline

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER FDA Label Details

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER FDA Submission History

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER FDA Documents

Data Sources

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Details

Companies

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER Approval History

What LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER Treats

Other

Active Pipeline

Key Completed Trials

Trial Timeline

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER FDA Label Details

Related LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER Products

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER FDA Submission History

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER FDA Documents

Data Sources

Competitive Analysis