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FDA NDA · NDA021128

CHILDREN'S MOTRIN COLD

Sponsor: KENVUE BRANDS

APPLICATION
NDA021128
TYPE
NDA
ORIGINAL APPROVAL
2000-08-01
LATEST ACTION
2017-04-03
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Over-the-counter

Products

CHILDREN'S MOTRIN COLD · ReferenceOver-the-counter
IBUPROFEN 100MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 15MG/5ML · SUSPENSION · ORAL

Approval history

2017-04-03Labeling · Supplement 10 · standard — Label ↗AP
2009-04-29Labeling · Supplement 9 · standard — Letter ↗AP
2005-12-21Labeling · Supplement 7 · standard — Letter ↗AP
2005-04-20Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP
2003-12-19Labeling · Supplement 3 · standard — Letter ↗AP
2001-05-02Manufacturing (CMC) · Supplement 1 · standardAP
2000-08-01Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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