APPLICATION
ANDA070436
TYPE
ANDA
ORIGINAL APPROVAL
1985-08-21
LATEST ACTION
2016-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 400MG · TABLET · ORAL
Approval history
2016-05-09Labeling · Supplement 24 · standardAP
2016-05-06Labeling · Supplement 25 · standardAP
1992-09-23Manufacturing (CMC) · Supplement 7AP
1991-08-09Labeling · Supplement 20AP
1991-08-07Manufacturing (CMC) · Supplement 16AP
1991-04-24Labeling · Supplement 19AP
1990-11-19Manufacturing (CMC) · Supplement 17AP
1989-06-15Manufacturing (CMC) · Supplement 11AP
1989-04-15Manufacturing (CMC) · Supplement 10AP
1989-03-24Labeling · Supplement 13AP
1988-07-08Labeling · Supplement 9AP
1988-04-04Labeling · Supplement 8AP
1986-10-28Manufacturing (CMC) · Supplement 4AP
1986-04-30Manufacturing (CMC) · Supplement 2AP
1986-03-25Manufacturing (CMC) · Supplement 1AP
1985-08-21OriginalAP
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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