Levetiracetam

Treats partial-onset seizures. ANDA 90767, held by Rising. Levetiracetam.

As of Nov 15, 2026, ANDA 90767 (Levetiracetam), held by Rising, was first approved by FDA on Jul 28, 2010, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 28, 2010
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam is 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 14 submissions below

Date	Submission	Status	Documents
Jul 28, 2010	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 14 submissions, including labeling and manufacturing supplements


Feb 25, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Feb 25, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Jul 15, 2022	Supplement 13Manufacturing	Approved	None posted
Jun 17, 2022	Supplement 7Labeling · Standard review	Approved	None posted
Jun 17, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Jun 17, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Jun 17, 2022	Supplement 11Labeling · Standard review	Approved	None posted
Jun 17, 2022	Supplement 12Labeling · Standard review	Approved	None posted
Oct 2, 2015	Supplement 1Labeling	Approved	None posted
Oct 2, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Oct 2, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Oct 2, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Oct 2, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jul 28, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90767
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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