Drugs@FDA document

OPANA ER Letter · NDA 201655 SUPPL-20

Drugs@FDA document · ENDO PHARMS · Apr 22, 2016

Key facts

Drug name OPANA ER
Document type Letter
Application NDA201655
Submission SUPPL-20
Company ENDO PHARMS
Document date Apr 22, 2016
FDA document accessdata.fda.gov

At a glance

  • REMS-Modified Document categories
  • 10–99 Documents for this application
  • 1–9 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