APPLICATION
ANDA204469
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-28
LATEST ACTION
2025-04-01
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
2025-04-01Labeling · Supplement 8 · standardAP
2025-04-01Labeling · Supplement 10 · standardAP
2025-04-01Labeling · Supplement 7 · standardAP
2020-04-06Manufacturing (CMC) · Supplement 3AP
2018-03-28UNKNOWN · OriginalAP
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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