APPLICATION
ANDA076117
TYPE
ANDA
ORIGINAL APPROVAL
2001-11-20
LATEST ACTION
2015-03-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
IBUPROFENOver-the-counter
IBUPROFEN 200MG · TABLET · ORAL
Approval history
2015-03-18Labeling · Supplement 5AP
2002-10-01Manufacturing (CMC) · Supplement 1AP
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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