Levetiracetam

ANDA 90484, held by Orbion Pharms. Levetiracetam.

As of Nov 15, 2026, ANDA 90484 (Levetiracetam), held by Orbion Pharms, was first approved by FDA on Aug 5, 2010, with 12 approved supplements and 0 published complete response letters.

First approved: Aug 5, 2010
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Aug 5, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levetiracetam1GM · tablet;oral	Levetiracetam	Rx

All 13 submissions, including labeling and manufacturing supplements


Dec 19, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Dec 9, 2014	Supplement 3Labeling	Approved	None posted
Dec 9, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Dec 9, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Jan 12, 2012	Supplement 2REMS	Approved	None posted
Nov 17, 2010	Supplement 1Labeling	Approved	None posted
Aug 5, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90484
Drugs@FDA: Overview at FDA
Company: Orbion 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