Levetiracetam

Treats partial-onset seizures. ANDA 216375, held by Alkem Labs Ltd. Levetiracetam.

As of Nov 15, 2026, ANDA 216375 (Levetiracetam), held by Alkem Labs Ltd, was first approved by FDA on May 27, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: May 27, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam tablets are indicated for adjunctive therapy for the treatment of:

Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy 1.1 Partial-Onset Seizures

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 27, 2022	Original application	Approved	None posted

Products

4 strengths and forms


Levetiracetam250MG · tablet;oral	Levetiracetam	Rx
Levetiracetam500MG · tablet;oral	Levetiracetam	Rx
Levetiracetam750MG · tablet;oral	Levetiracetam	Rx
Levetiracetam1GM · tablet;oral	Levetiracetam	Rx

All 2 submissions, including labeling and manufacturing supplements


Feb 21, 2025	Supplement 2Labeling · Standard review	Approved	None posted
May 27, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 216375
Drugs@FDA: Overview at FDA
Company: Alkem Laboratories

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