APPLICATION
ANDA076925
TYPE
ANDA
ORIGINAL APPROVAL
2004-09-23
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
IBUPROFENPrescription
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL
Approval history
2024-11-21Labeling · Supplement 52 · standardAP
2021-04-28Labeling · Supplement 47 · standardAP
2019-07-22Labeling · Supplement 41 · standardAP
2017-04-18Labeling · Supplement 36 · standardAP
2016-05-09Labeling · Supplement 33 · standardAP
2013-08-13Labeling · Supplement 29AP
2008-09-04Labeling · Supplement 20AP
2006-07-03Labeling · Supplement 11AP
2006-03-22Labeling · Supplement 10AP
2004-09-23OriginalAP
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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