Drug application

ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE)

Drugs@FDA NDA 022113 · HALEON US HOLDINGS

Key facts

Drug name ADVIL ALLERGY AND CONGESTION RELIEF
Active ingredients CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE
Application type NDA
Application number 022113
Company HALEON US HOLDINGS
Dosage forms TABLET, ORAL
Strength 4MG;200MG;10MG
Marketing status Over-the-counter
Reference listed drug Yes
Latest submission class Type 4 - New Combination
Latest submission status date Dec 21, 2011

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

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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