Drugs@FDA document

INDOCIN Letter · NDA 016059 SUPPL-101

Drugs@FDA document · ZYLA LIFE SCIENCES · Apr 29, 2021

Key facts

Drug name INDOCIN
Document type Letter
Application NDA016059
Submission SUPPL-101
Company ZYLA LIFE SCIENCES
Document date Apr 29, 2021
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

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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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