Drugs@FDA document

AMBRISENTAN REMS · ANDA 210784 APPL-0

Drugs@FDA document · SUN PHARM · Apr 1, 2019

Key facts

Drug name AMBRISENTAN
Document type REMS
Application ANDA210784
Submission APPL-0
Company SUN PHARM
Document date Apr 1, 2019
FDA document accessdata.fda.gov

At a glance

  • 10–99 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