Drug application

CHILDREN'S ADVIL (IBUPROFEN)

Drugs@FDA NDA 020589 · HALEON US HOLDINGS

Key facts

Drug name CHILDREN'S ADVIL
Active ingredients IBUPROFEN
Application type NDA
Application number 020589
Company HALEON US HOLDINGS
Dosage forms SUSPENSION, ORAL
Strength 100MG/5ML
Marketing status Over-the-counter
Reference listed drug No
Latest submission class Type 8 - Partial Rx to OTC Switch
Latest submission status date Jun 27, 1996

At a glance

  • 1–9 Submissions
  • 10–99 Supplements
  • 1–9 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 · Source date:

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