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

Yes, LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER is FDA approved (first approved 2011-07-07) and manufactured by KNACK.

Who makes LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER?

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER is manufactured by KNACK.

Data updated: Mar 10, 2026

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Q: What is LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER used for?

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

LEVOFLOXACIN

Approved 2011-07-07

Jump to: Indications Approvals Trials Competitors Safety Patents

Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 2011-07-07
Routes: INJECTION
Dosage Forms: INJECTABLE

Companies

KNACK Pfizer Baxter GLAND Hikma Fresenius Kabi INFORLIFE EUGIA PHARMA

Active Ingredient: LEVOFLOXACIN

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER Approval History

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What LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER Treats

8 FDA approvals

Originally approved for its first indication in 2011 . Covers 8 distinct patient populations.

Other (8)

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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.

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER FDA Label Details

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Data Sources

FDA Approval: ANDA216164 → Trials: ClinicalTrials.gov →

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