APPLICATION
ANDA206568
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-21
LATEST ACTION
2023-09-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter
Products
IBUPROFENOver-the-counter
IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT · CAPSULE · ORAL
Approval history
2023-09-19Labeling · Supplement 4 · standardAP
2023-09-19Labeling · Supplement 9 · standardAP
2023-09-19Labeling · Supplement 24 · standardAP
2016-06-21UNKNOWN · 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.