Drug application

BISOPROLOL FUMARATE (BISOPROLOL FUMARATE)

Drugs@FDA ANDA 218303 · MICRO LABS

Key facts

Drug name BISOPROLOL FUMARATE
Active ingredients BISOPROLOL FUMARATE
Application type ANDA
Application number 218303
Company MICRO LABS
Dosage forms TABLET, ORAL
Strength 5MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Mar 9, 2026

At a glance

  • 1–9 Submissions
  • 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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