Drugs@FDA document

TRALEMENT Review · NDA 209376 ORIG-1

Drugs@FDA document · AM REGENT · Feb 22, 2021

Key facts

Drug name TRALEMENT
Document type Review
Application NDA209376
Submission ORIG-1
Company AM REGENT
Document date Feb 22, 2021
FDA document accessdata.fda.gov

At a glance

  • Administrative Doc & Correspondence 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