Drug application

MIRABEGRON (MIRABEGRON)

Drugs@FDA ANDA 217989 · QILU

Key facts

Drug name MIRABEGRON
Active ingredients MIRABEGRON
Application type ANDA
Application number 217989
Company QILU
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength 25MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Jun 30, 2025

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 1–9 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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