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Data updated: Mar 10, 2026

LEVETIRACETAM IN SODIUM CHLORIDE

LEVETIRACETAM
Neurology Approved 2011-11-09
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
9
Indications
--
Phase 3 Trials
14
Years on Market

Details

Status
Prescription
First Approved
2011-11-09
Routes
INTRAVENOUS
Dosage Forms
INJECTABLE

Companies

CAPLIN GLAND Hikma Fresenius Kabi B BRAUN MEDICAL NEXUS EUGIA PHARMA HQ SPCLT PHARMA Baxter
Active Ingredient: LEVETIRACETAM

LEVETIRACETAM IN SODIUM CHLORIDE Approval History

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What LEVETIRACETAM IN SODIUM CHLORIDE Treats

4 indications

LEVETIRACETAM IN SODIUM CHLORIDE is approved for 4 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Partial-Onset Seizures
  • Myoclonic Seizures
  • Primary Generalized Tonic-Clonic Seizures
  • Epilepsy
Source: FDA Label

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Trial Timeline

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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.

LEVETIRACETAM IN SODIUM CHLORIDE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial-onset seizures Myoclonic seizures in patients with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures 1.1 Partial-Onset Seizures Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam in Sodium Chloride Injec...

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Data Sources

FDA Approval: ANDA219562 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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