Vigabatrin

ANDA 210042, held by Amneal Pharms. Vigabatrin.

As of Nov 15, 2026, ANDA 210042 (Vigabatrin), held by Amneal Pharms, was first approved by FDA on Jun 22, 2022, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 22, 2022
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 22, 2022	Original application	Approved	REMS

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vigabatrin500MG · tablet;oral	Vigabatrin	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Mar 18, 2026	Supplement 9REMS	Approved	None posted
Dec 17, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Sep 12, 2024	Supplement 6REMS	Approved	None posted
Oct 12, 2022	Supplement 1REMS	Approved	None posted
Jun 22, 2022	Original application	Approved	REMS

Identifiers

Application: ANDA 210042
Drugs@FDA: Overview at FDA
Company: Amneal 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