Drug application

CARBAMAZEPINE (CARBAMAZEPINE)

Drugs@FDA ANDA 216404 · INGENUS PHARMS LLC

Key facts

Drug name CARBAMAZEPINE
Active ingredients CARBAMAZEPINE
Application type ANDA
Application number 216404
Company INGENUS PHARMS LLC
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 100MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Dec 2, 2022

At a glance

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

Browse all Drugs@FDA applications