Levetiracetam

Treats partial-onset seizures. ANDA 202869, held by Hospira Inc. Levetiracetam.

As of Nov 15, 2026, ANDA 202869 (Levetiracetam), held by Hospira Inc, was first approved by FDA on Apr 6, 2012, with 7 approved supplements and 0 published complete response letters.

First approved: Apr 6, 2012
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Levetiracetam injection is indicated for adjunctive therapy for the treatment of: o Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. o Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Apr 6, 2012	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levetiracetam500MG/5ML (100MG/ML) · injectable;intravenous	Levetiracetam	Rx

All 8 submissions, including labeling and manufacturing supplements


Jul 13, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Jul 13, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Jul 13, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Jul 13, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Jul 13, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Jul 13, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Jul 13, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Apr 6, 2012	Original application	Approved	Review

Identifiers

Application: ANDA 202869
Drugs@FDA: Overview at FDA
Company: Hospira

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