Levetiracetam

Treats partial-onset seizures. ANDA 212688, held by Yabao Pharm. Levetiracetam.

As of Nov 15, 2026, ANDA 212688 (Levetiracetam), held by Yabao Pharm, was first approved by FDA on Jun 11, 2020, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 11, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.

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
Jun 11, 2020	Original application	Approved	None posted

Products

2 strengths and forms


Levetiracetam750MG · tablet, extended release;oral	Levetiracetam	Rx
Levetiracetam500MG · tablet, extended release;oral	Levetiracetam	Rx

All 2 submissions, including labeling and manufacturing supplements


Jul 20, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Jun 11, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 212688
Drugs@FDA: Overview at FDA
Company: Yabao Pharm

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