Levetiracetam In Sodium Chloride

Treats partial-onset seizures. NDA 202543, held by Hq Spclt Pharma. Levetiracetam.

As of Nov 15, 2026, NDA 202543 (Levetiracetam In Sodium Chloride), held by Hq Spclt Pharma, was first approved by FDA on Nov 9, 2011, with 12 approved supplements and 0 published complete response letters.

First approved: Nov 9, 2011
Review: Standard
Supplements approved: 12
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; all 13 submissions below

Date	Submission	Status	Documents
Nov 9, 2011	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

4 strengths and forms


Levetiracetam In Sodium Chloride500MG/100ML (5MG/ML) · injectable;intravenous	Levetiracetam	RxReference drug
Levetiracetam In Sodium Chloride1GM/100ML (10MG/ML) · injectable;intravenous	Levetiracetam	RxReference drug
Levetiracetam In Sodium Chloride1.5GM/100ML (15MG/ML) · injectable;intravenous	Levetiracetam	RxReference drug
Levetiracetam In Sodium Chloride250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;intravenous	Levetiracetam	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Mar 12, 2024	Supplement 24Labeling · Standard review	Approved	Label Letter
Apr 13, 2021	Supplement 19Labeling · Standard review	Approved	Label Letter
Nov 21, 2019	Supplement 15Labeling · Standard review	Approved	Label Letter
Jul 12, 2018	Supplement 11Labeling · Standard review	Approved	Letter Label
Jun 12, 2017	Supplement 10Labeling · Standard review	Approved	Label Letter
Nov 18, 2016	Supplement 8Labeling · Standard review	Approved	Letter Label
Nov 18, 2016	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 14, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 3, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 4, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 7, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 9, 2012	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 9, 2011	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 202543
Drugs@FDA: Overview at FDA
Company: HQ Specialty Pharma

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