Drugs@FDA document

AUSTEDO XR Review · NDA 216354 ORIG-1

Drugs@FDA document · TEVA · Jan 26, 2024

Key facts

Drug name AUSTEDO XR
Document type Review
Application NDA216354
Submission ORIG-1
Company TEVA
Document date Jan 26, 2024
FDA document accessdata.fda.gov

At a glance

  • 10–99 Documents for this application
  • None USP chapters cited in this application's documents

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