Drug application

CARBAMAZEPINE (CARBAMAZEPINE)

Drugs@FDA ANDA 075948 · APOTEX

Key facts

Drug name CARBAMAZEPINE
Active ingredients CARBAMAZEPINE
Application type ANDA
Application number 075948
Company APOTEX
Dosage forms TABLET, ORAL
Strength 200MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Feb 27, 2002

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • No FDA letters on file
  • No 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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