APPLICATION
ANDA091625
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-15
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IBUPROFENPrescription
IBUPROFEN 800MG · TABLET · ORAL
IBUPROFENPrescription
IBUPROFEN 400MG · TABLET · ORAL
IBUPROFENPrescription
IBUPROFEN 600MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 21 · standardAP
2021-04-28Labeling · Supplement 14 · standardAP
2021-04-01Labeling · Supplement 11 · standardAP
2019-07-22Labeling · Supplement 8 · standardAP
2015-09-15OriginalAP
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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