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CHILDREN'S MOTRIN COLD

NDA · New Drug Application · Sponsor: KENVUE BRANDS · Approved 2000-08-01

Drug application

FDA Application #
NDA021128
Application type
New Drug Application
Brand name
CHILDREN'S MOTRIN COLD
Generic name
Ibuprofen
Active ingredients
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form
SUSPENSION
Route
ORAL
Marketing status
Over-the-counter
Sponsor
KENVUE BRANDS
First approval
2000-08-01

Source

Authoritative
Drugs@FDA application overview
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