APPLICATION
ANDA203599
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-07
LATEST ACTION
2020-08-06
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
2020-08-06Manufacturing (CMC) · Supplement 6 · unknownAP
2017-01-17Labeling · Supplement 2 · standardAP
2016-09-07UNKNOWN · 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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