Drug application

IBUPROFEN (IBUPROFEN)

Drugs@FDA ANDA 217236 · PATHEON SOFTGELS

Key facts

Drug name IBUPROFEN
Active ingredients IBUPROFEN
Application type ANDA
Application number 217236
Company PATHEON SOFTGELS
Dosage forms CAPSULE, ORAL
Strength EQ 200MG FREE ACID AND POTASSIUM SALT
Marketing status Over-the-counter
Reference listed drug No
Latest submission status date Feb 13, 2024

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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