APPLICATION
ANDA077349
TYPE
ANDA
ORIGINAL APPROVAL
2005-06-21
LATEST ACTION
2022-11-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
IBUPROFENOver-the-counter
IBUPROFEN 200MG · TABLET · ORAL
Approval history
2022-11-15Labeling · Supplement 43 · standardAP
2022-11-15Labeling · Supplement 34 · standardAP
2022-11-15Labeling · Supplement 32 · standardAP
2012-09-21Labeling · Supplement 14AP
2008-01-16Labeling · Supplement 8AP
2006-03-22Labeling · Supplement 1AP
2005-06-21OriginalAP
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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