Drugs@FDA document

VIGABATRIN REMS · ANDA 212626 ORIG-1

Drugs@FDA document · SPECGX LLC · Nov 3, 2023

Key facts

Drug name VIGABATRIN
Document type REMS
Application ANDA212626
Submission ORIG-1
Company SPECGX LLC
Document date Nov 3, 2023
FDA document accessdata.fda.gov

At a glance

  • 1–9 Documents for this application

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA documents

Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application documents · Source date:

Browse all Drugs@FDA documents