APPLICATION
ANDA077114
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-18
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 800MG · TABLET · ORAL
IBUPROFENDiscontinued
IBUPROFEN 400MG · TABLET · ORAL
IBUPROFENDiscontinued
IBUPROFEN 600MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 15 · standardAP
2021-04-28Labeling · Supplement 14 · standardAP
2019-07-22Labeling · Supplement 13 · standardAP
2016-05-09Labeling · Supplement 12 · standardAP
2008-09-04Labeling · Supplement 9AP
2006-07-03Labeling · Supplement 2AP
2006-03-02Labeling · Supplement 1AP
2005-07-18OriginalAP
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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