Drug application

PREDNISOLONE (PREDNISOLONE)

Drugs@FDA ANDA 080354 · WATSON LABS

Key facts

Drug name PREDNISOLONE
Active ingredients PREDNISOLONE
Application type ANDA
Application number 080354
Company WATSON LABS
Dosage forms TABLET, ORAL
Strength 5MG
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission status date Jan 17, 1972

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 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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