Vigabatrin

ANDA 213390, held by Propel Pharma. Vigabatrin.

As of Nov 15, 2026, ANDA 213390 (Vigabatrin), held by Propel Pharma, was first approved by FDA on Jul 29, 2021, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 29, 2021
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 29, 2021	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Sep 12, 2024	Supplement 3REMS	Approved	None posted
Oct 26, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Oct 12, 2022	Supplement 2REMS	Approved	None posted
Jul 29, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 213390
Drugs@FDA: Overview at FDA
Company: Propel Pharma

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