APPLICATION
NDA019784
TYPE
NDA
ORIGINAL APPROVAL
1989-12-12
LATEST ACTION
1989-12-12
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
IBUDiscontinued
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL
Approval history
1989-12-12Type 3 - New Dosage Form · Original · standardAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.