Drug application

PREDNISOLONE (PREDNISOLONE)

Drugs@FDA ANDA 080531 · CHARTWELL MOLECULAR

Key facts

Drug name PREDNISOLONE
Active ingredients PREDNISOLONE
Application type ANDA
Application number 080531
Company CHARTWELL MOLECULAR
Dosage forms TABLET, ORAL
Strength 5MG
Marketing status Prescription
TE codes BX
Reference listed drug No
Latest submission status date May 31, 1974

At a glance

  • 1–9 Submissions
  • 1–9 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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