Vigabatrin

ANDA 209824, held by Teva Pharms USA. Vigabatrin.

As of Nov 15, 2026, ANDA 209824 (Vigabatrin), held by Teva Pharms USA, was first approved by FDA on Apr 23, 2018, with 10 approved supplements and 0 published complete response letters.

First approved: Apr 23, 2018
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Apr 23, 2018	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vigabatrin500MG/PACKET · for solution;oral	Vigabatrin	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Mar 18, 2026	Supplement 15REMS	Approved	None posted
Sep 12, 2024	Supplement 13REMS	Approved	None posted
Oct 27, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Oct 12, 2022	Supplement 11REMS	Approved	None posted
Oct 2, 2020	Supplement 9REMS	Approved	None posted
Aug 3, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Aug 3, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Apr 17, 2020	Supplement 8REMS	Approved	None posted
Sep 12, 2019	Supplement 5REMS	Approved	None posted
May 30, 2019	Supplement 2REMS	Approved	None posted
Apr 23, 2018	Original application	Approved	REMS

Identifiers

Application: ANDA 209824
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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