Drug application

DAURISMO (GLASDEGIB MALEATE)

Drugs@FDA NDA 210656 · PFIZER

Key facts

Drug name DAURISMO
Active ingredients GLASDEGIB MALEATE
Application type NDA
Application number 210656
Company PFIZER
Dosage forms TABLET, ORAL
Strength EQ 25MG BASE
Marketing status Prescription
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Nov 21, 2018

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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