APPLICATION
ANDA071215
TYPE
ANDA
ORIGINAL APPROVAL
1986-06-26
LATEST ACTION
1989-02-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MEDIPRENDiscontinued
IBUPROFEN 200MG · TABLET · ORAL
Approval history
1989-02-14Manufacturing (CMC) · Supplement 19AP
1988-09-09Labeling · Supplement 17AP
1988-04-07Manufacturing (CMC) · Supplement 16AP
1988-04-07Manufacturing (CMC) · Supplement 14AP
1988-04-07Manufacturing (CMC) · Supplement 15AP
1987-10-20Manufacturing (CMC) · Supplement 11AP
1987-09-10Manufacturing (CMC) · Supplement 6AP
1987-09-10Manufacturing (CMC) · Supplement 5AP
1986-11-05Manufacturing (CMC) · Supplement 4AP
1986-11-05Manufacturing (CMC) · Supplement 2AP
1986-11-05Manufacturing (CMC) · Supplement 3AP
1986-06-26OriginalAP
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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