← FDA DRUG APPROVALS

FDA NDA · NDA020476

MOTRIN

Sponsor: MCNEIL

APPLICATION
NDA020476
TYPE
NDA
ORIGINAL APPROVAL
1995-05-25
LATEST ACTION
2002-02-04
ROUTE
ORAL
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued

Products

MOTRINDiscontinued
IBUPROFEN 40MG/ML · SUSPENSION/DROPS · ORAL

Approval history

2002-02-04Labeling · Supplement 2 · standardReviewAP
2001-05-14Manufacturing (CMC) · Supplement 3 · standardAP
1995-05-25Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →