APPLICATION
ANDA071935
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-13
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IBUPROFENPrescription
IBUPROFEN 800MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 36 · standardAP
2021-04-28Labeling · Supplement 34 · standardAP
2019-07-22Labeling · Supplement 33 · standardAP
2016-05-09Labeling · Supplement 31 · standardAP
2007-12-26Labeling · Supplement 27AP
2006-08-07Labeling · Supplement 23AP
2006-07-03Labeling · Supplement 22AP
2001-09-25Manufacturing (CMC) · Supplement 17AP
2000-04-12Manufacturing (CMC) · Supplement 15AP
2000-04-12Manufacturing (CMC) · Supplement 13AP
2000-04-12Manufacturing (CMC) · Supplement 16AP
1999-09-24Manufacturing (CMC) · Supplement 11AP
1999-08-30Labeling · Supplement 14AP
1999-02-11Manufacturing (CMC) · Supplement 10AP
1998-01-20Manufacturing (CMC) · Supplement 8AP
1997-07-24Manufacturing (CMC) · Supplement 9AP
1992-01-30Labeling · Supplement 7AP
1988-06-30Manufacturing (CMC) · Supplement 4AP
1988-03-28Labeling · Supplement 3AP
1988-02-17Manufacturing (CMC) · Supplement 1AP
1988-02-17Manufacturing (CMC) · Supplement 2AP
1987-10-13OriginalAP
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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