APPLICATION
ANDA070088
TYPE
ANDA
ORIGINAL APPROVAL
1985-02-08
LATEST ACTION
1988-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IBUDiscontinued
IBUPROFEN 600MG · TABLET · ORAL
Approval history
1988-10-07Labeling · Supplement 8AP
1988-02-08Labeling · Supplement 7AP
1987-03-24Manufacturing (CMC) · Supplement 6AP
1987-03-24Manufacturing (CMC) · Supplement 4AP
1986-01-22Manufacturing (CMC) · Supplement 3AP
1985-04-09Manufacturing (CMC) · Supplement 2AP
1985-04-09Manufacturing (CMC) · Supplement 1AP
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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