APPLICATION
ANDA071268
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-15
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IBUPROFENPrescription
IBUPROFEN 800MG · TABLET · ORAL
IBUPROFENPrescription
IBUPROFEN 600MG · TABLET · ORAL
IBUPROFENPrescription
IBUPROFEN 400MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 17 · standardAP
2021-04-28Labeling · Supplement 16 · standardAP
2019-07-22Labeling · Supplement 14 · standardAP
2016-05-09Labeling · Supplement 13 · standardAP
1989-01-23Labeling · Supplement 12AP
1988-08-10Labeling · Supplement 11AP
1987-12-18Manufacturing (CMC) · Supplement 9AP
1987-12-18Manufacturing (CMC) · Supplement 10AP
1987-12-18Manufacturing (CMC) · Supplement 8AP
1987-10-02Manufacturing (CMC) · Supplement 4AP
1987-07-06Manufacturing (CMC) · Supplement 7AP
1987-07-06Manufacturing (CMC) · Supplement 5AP
1987-07-06Manufacturing (CMC) · Supplement 6AP
1987-05-14Manufacturing (CMC) · Supplement 1AP
1987-05-14Manufacturing (CMC) · Supplement 2AP
1987-01-21Manufacturing (CMC) · Supplement 3AP
1986-10-15OriginalAP
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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