Drug application

URSODIOL (URSODIOL)

Drugs@FDA ANDA 077895 · IMPAX LABS INC

Key facts

Drug name URSODIOL
Active ingredients URSODIOL
Application type ANDA
Application number 077895
Company IMPAX LABS INC
Dosage forms CAPSULE, ORAL
Strength 300MG
Marketing status Discontinued
Reference listed drug No
Latest submission status date Jul 27, 2006

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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