APPLICATION
ANDA070745
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-23
LATEST ACTION
1995-08-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUDiscontinued
IBUPROFEN 800MG · TABLET · ORAL
Approval history
1995-08-11Manufacturing (CMC) · Supplement 13AP
1995-02-27Labeling · Supplement 15AP
1995-02-15Labeling · Supplement 14AP
1994-09-30Manufacturing (CMC) · Supplement 10AP
1994-09-30Manufacturing (CMC) · Supplement 11AP
1991-10-17Labeling · Supplement 9AP
1991-08-06Labeling · Supplement 8AP
1989-10-27Labeling · Supplement 7AP
1989-06-08Labeling · Supplement 6AP
1989-01-27Manufacturing (CMC) · Supplement 4AP
1989-01-10Labeling · Supplement 5AP
1988-10-07Labeling · Supplement 3AP
1988-03-01Labeling · Supplement 2AP
1986-09-03Labeling · Supplement 1AP
1986-07-23OriginalAP
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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