Drugs@FDA document

COUMADIN Letter · NDA 009218 SUPPL-116

Drugs@FDA document · BRISTOL MYERS SQUIBB · Sep 12, 2016

Key facts

Drug name COUMADIN
Document type Letter
Application NDA009218
Submission SUPPL-116
Company BRISTOL MYERS SQUIBB
Document date Sep 12, 2016
FDA document accessdata.fda.gov

At a glance

  • Labeling-Package Insert Document categories
  • 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