Drug application

AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)

Drugs@FDA ANDA 074895 · TEVA

Key facts

Drug name AMIODARONE HYDROCHLORIDE
Active ingredients AMIODARONE HYDROCHLORIDE
Application type ANDA
Application number 074895
Company TEVA
Dosage forms TABLET, ORAL
Strength 200MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Apr 16, 1999

At a glance

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