Drug application

PEGANONE (ETHOTOIN)

Drugs@FDA NDA 010841 · RECORDATI RARE

Key facts

Drug name PEGANONE
Active ingredients ETHOTOIN
Application type NDA
Application number 010841
Company RECORDATI RARE
Dosage forms TABLET, ORAL
Strength 250MG
Marketing status Discontinued
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Apr 22, 1957

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents

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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