Levetiracetam In Sodium Chloride

Treats partial-onset seizures. ANDA 208619, held by Fresenius Kabi USA. Levetiracetam.

As of Nov 15, 2026, ANDA 208619 (Levetiracetam In Sodium Chloride), held by Fresenius Kabi USA, was first approved by FDA on Jan 31, 2023, with 0 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2023
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jan 31, 2023	Original application	Approved	None posted

Products

3 strengths and forms


Levetiracetam In Sodium Chloride500MG/100ML (5MG/ML) · injectable;intravenous	Levetiracetam	Rx
Levetiracetam In Sodium Chloride1GM/100ML (10MG/ML) · injectable;intravenous	Levetiracetam	Rx
Levetiracetam In Sodium Chloride1.5GM/100ML (15MG/ML) · injectable;intravenous	Levetiracetam	Rx

Identifiers

Application: ANDA 208619
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters