APPLICATION
ANDA071335
TYPE
ANDA
ORIGINAL APPROVAL
1986-11-25
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IBUPROFENPrescription
IBUPROFEN 600MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 45 · standardAP
2021-04-28Labeling · Supplement 42 · standardAP
2019-07-22Labeling · Supplement 41 · standardAP
2016-05-09Labeling · Supplement 39 · standardAP
2007-12-26Labeling · Supplement 35AP
2006-08-15Labeling · Supplement 31AP
2006-05-16Labeling · Supplement 30AP
2001-09-25Manufacturing (CMC) · Supplement 25AP
2000-04-12Manufacturing (CMC) · Supplement 24AP
2000-04-12Manufacturing (CMC) · Supplement 23AP
2000-04-12Manufacturing (CMC) · Supplement 21AP
1999-09-24Manufacturing (CMC) · Supplement 19AP
1999-08-30Labeling · Supplement 22AP
1999-02-11Manufacturing (CMC) · Supplement 18AP
1998-01-20Manufacturing (CMC) · Supplement 15AP
1997-07-24Manufacturing (CMC) · Supplement 17AP
1992-01-30Labeling · Supplement 14AP
1989-01-19Labeling · Supplement 13AP
1988-10-11Labeling · Supplement 12AP
1988-04-05Manufacturing (CMC) · Supplement 9AP
1988-04-05Manufacturing (CMC) · Supplement 7AP
1988-04-05Manufacturing (CMC) · Supplement 8AP
1988-03-28Labeling · Supplement 10AP
1988-01-12Manufacturing (CMC) · Supplement 4AP
1988-01-07Manufacturing (CMC) · Supplement 5AP
1987-10-08Manufacturing (CMC) · Supplement 3AP
1987-06-24Manufacturing (CMC) · Supplement 1AP
1986-11-25OriginalAP
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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