APPLICATION
ANDA076460
TYPE
ANDA
ORIGINAL APPROVAL
2003-11-26
LATEST ACTION
2014-11-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
IBUPROFENOver-the-counter
IBUPROFEN 200MG · TABLET · ORAL
Approval history
2014-11-20Manufacturing (CMC) · Supplement 7AP
2014-11-03Labeling · Supplement 6AP
2014-07-10Labeling · Supplement 4AP
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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