Drugs@FDA document

ESBRIET Label · NDA 022535 SUPPL-1

Drugs@FDA document · LEGACY · Oct 7, 2015

Key facts

Drug name ESBRIET
Document type Label
Application NDA022535
Submission SUPPL-1
Company LEGACY
Document date Oct 7, 2015
FDA document accessdata.fda.gov

At a glance

  • Manufacturing (CMC) Document categories
  • 10–99 Documents for this application
  • 1–9 USP chapters cited in this application's documents

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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:

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