Levetiracetam

ANDA 205102, held by China Resources. Levetiracetam.

As of Nov 15, 2026, ANDA 205102 (Levetiracetam), held by China Resources, was first approved by FDA on Dec 16, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 16, 2015
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below


Dec 16, 2015	Original application	Tentative approval	None posted
Dec 16, 2015	Original application	Approved	None posted
Dec 16, 2015	Original application	Approved	Letter

Products

4 strengths and forms


Levetiracetam250MG · tablet;oral	Levetiracetam	None (tentative approval)
Levetiracetam750MG · tablet;oral	Levetiracetam	None (tentative approval)
Levetiracetam1GM · tablet;oral	Levetiracetam	Discontinued
Levetiracetam500MG · tablet;oral	Levetiracetam	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Aug 12, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Aug 12, 2025	Supplement 2Labeling · Standard review	Approved	None posted
Aug 12, 2025	Supplement 1Labeling · Standard review	Approved	None posted
Dec 16, 2015	Original application	Tentative approval	None posted
Dec 16, 2015	Original application	Approved	None posted
Dec 16, 2015	Original application	Approved	Letter

Identifiers

Application: ANDA 205102
Drugs@FDA: Overview at FDA
Company: China Resources

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