Drugs@FDA document

MEKINIST Label · NDA 204114 SUPPL-34

Drugs@FDA document · NOVARTIS · Mar 21, 2025

Key facts

Drug name MEKINIST
Document type Label
Application NDA204114
Submission SUPPL-34
Company NOVARTIS
Document date Mar 21, 2025

At a glance

  • Efficacy-Labeling Change With Clinical Data 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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