Drug application

CARBAMAZEPINE (CARBAMAZEPINE)

Drugs@FDA ANDA 219939 · ALEMBIC

Key facts

Drug name CARBAMAZEPINE
Active ingredients CARBAMAZEPINE
Application type ANDA
Application number 219939
Company ALEMBIC
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 100MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jul 25, 2025

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

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