APPLICATION
ANDA076359
TYPE
ANDA
ORIGINAL APPROVAL
2004-01-16
LATEST ACTION
2012-11-26
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued, Over-the-counter
Products
IBUPROFENDiscontinued
IBUPROFEN 50MG · TABLET, CHEWABLE · ORAL
IBUPROFENOver-the-counter
IBUPROFEN 100MG · TABLET, CHEWABLE · ORAL
Approval history
2012-11-26Labeling · Supplement 31AP
2011-01-21Labeling · Supplement 26AP
2008-08-22Labeling · Supplement 22AP
2006-03-17Labeling · Supplement 15AP
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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