Drugs@FDA document

CLARINEX-D 12 HOUR Letter · NDA 021313 SUPPL-12

Drugs@FDA document · ORGANON LLC · Mar 18, 2019

Key facts

Drug name CLARINEX-D 12 HOUR
Document type Letter
Application NDA021313
Submission SUPPL-12
Company ORGANON LLC
Document date Mar 18, 2019

At a glance

  • Labeling-Package Insert 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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