APPLICATION
ANDA079174
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-10
LATEST ACTION
2018-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
IBUPROFENOver-the-counter
IBUPROFEN 200MG · TABLET · ORAL
Approval history
2018-04-11Labeling · Supplement 14 · standardAP
2018-04-11Manufacturing (CMC) · Supplement 10AP
2018-03-23Labeling · Supplement 17 · standardAP
2015-04-13Labeling · Supplement 1 · standardAP
2010-12-10OriginalAP
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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