Assyro AI

Orange Book product · Brand (NDA)

CHILDREN'S ADVIL

IBUPROFEN

Brand (NDA)NDA 020944OTC HALEON US HOLDINGS

At a glance

Dec 18, 1998

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 18, 1998

    27 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

IBUPROFEN

Strength

50MG

Dosage form

TABLET, CHEWABLE

Route

ORAL

TE code

Not listed

Application

NDA 020944

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.