APPLICATION
ANDA074916
TYPE
ANDA
ORIGINAL APPROVAL
1999-04-30
LATEST ACTION
2015-04-13
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Over-the-counter
Products
IBUPROFENOver-the-counter
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL
Approval history
2015-04-13Manufacturing (CMC) · Supplement 51 · unknownAP
2015-03-03Manufacturing (CMC) · Supplement 50 · unknownAP
2014-12-16Manufacturing (CMC) · Supplement 47AP
2012-11-26Labeling · Supplement 45 · standardAP
2010-05-13Labeling · Supplement 38AP
2007-11-28Labeling · Supplement 25AP
2007-11-28Labeling · Supplement 23AP
2007-11-28Labeling · Supplement 21AP
2007-11-28Labeling · Supplement 27AP
2002-10-25Manufacturing (CMC) · Supplement 6AP
2001-08-03Labeling · Supplement 5AP
2001-04-25Manufacturing (CMC) · Supplement 4AP
2001-01-29Manufacturing (CMC) · Supplement 3AP
2001-01-29Manufacturing (CMC) · Supplement 2AP
1999-12-13Labeling · Supplement 1AP
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.