Drug application

BUDESONIDE (BUDESONIDE)

Drugs@FDA ANDA 090379 · BARR LABS DIV TEVA

Key facts

Drug name BUDESONIDE
Active ingredients BUDESONIDE
Application type ANDA
Application number 090379
Company BARR LABS DIV TEVA
Dosage forms CAPSULE, DELAYED RELEASE, ORAL
Strength 3MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Apr 2, 2014

At a glance

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