Drug application

URSODIOL (URSODIOL)

Drugs@FDA ANDA 079082 · LANNETT CO INC

Key facts

Drug name URSODIOL
Active ingredients URSODIOL
Application type ANDA
Application number 079082
Company LANNETT CO INC
Dosage forms CAPSULE, ORAL
Strength 300MG
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Dec 15, 2008

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 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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