Drug application

CARBAMAZEPINE (CARBAMAZEPINE)

Drugs@FDA ANDA 078746 · TEVA PHARMS USA

Key facts

Drug name CARBAMAZEPINE
Active ingredients CARBAMAZEPINE
Application type ANDA
Application number 078746
Company TEVA PHARMS USA
Dosage forms CAPSULE, EXTENDED RELEASE, ORAL
Strength 100MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Sep 20, 2012

At a glance

  • 1–9 Submissions
  • None 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

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