Drug application

POMALYST (POMALIDOMIDE)

Drugs@FDA NDA 204026 · BRISTOL

Key facts

Drug name POMALYST
Active ingredients POMALIDOMIDE
Application type NDA
Application number 204026
Company BRISTOL
Dosage forms CAPSULE, ORAL
Strength 1MG
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Feb 8, 2013

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 10–99 Label versions
  • 1–9 Products
  • 10–99 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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