Levetiracetam

ANDA 207175, held by Hisun Pharm Hangzhou. Levetiracetam.

As of Nov 15, 2026, ANDA 207175 (Levetiracetam), held by Hisun Pharm Hangzhou, was first approved by FDA on Sep 28, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 28, 2017
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Sep 28, 2017	Original application	Approved	None posted

Products

2 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Nov 14, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Oct 23, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Apr 5, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Apr 5, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Apr 5, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Sep 28, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207175
Drugs@FDA: Overview at FDA
Company: Hisun Pharmaceutical (Hangzhou)

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