APPLICATION
ANDA072326
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-20
LATEST ACTION
1999-11-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FENOPROFEN CALCIUMDiscontinued
FENOPROFEN CALCIUM EQ 600MG BASE · TABLET · ORAL
Approval history
1999-11-04Manufacturing (CMC) · Supplement 9AP
1999-11-04Manufacturing (CMC) · Supplement 10AP
1998-12-01Manufacturing (CMC) · Supplement 8AP
1995-10-06Manufacturing (CMC) · Supplement 7AP
1991-04-15Manufacturing (CMC) · Supplement 6AP
1989-03-31Labeling · Supplement 5AP
1988-12-15Manufacturing (CMC) · Supplement 2AP
1988-12-15Manufacturing (CMC) · Supplement 3AP
1988-07-20Manufacturing (CMC) · Supplement 1AP
1988-04-20OriginalAP
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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