APPLICATION
ANDA072557
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-29
LATEST ACTION
2002-07-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FENOPROFEN CALCIUMDiscontinued
FENOPROFEN CALCIUM EQ 600MG BASE · TABLET · ORAL
Approval history
2002-07-29Manufacturing (CMC) · Supplement 9AP
2002-03-12Manufacturing (CMC) · Supplement 8AP
2002-02-22Manufacturing (CMC) · Supplement 7AP
2000-01-28Manufacturing (CMC) · Supplement 5AP
1998-11-05Manufacturing (CMC) · Supplement 4AP
1996-02-27Manufacturing (CMC) · Supplement 3AP
1993-01-27Labeling · Supplement 2AP
1992-06-12Labeling · Supplement 1AP
1988-08-29OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.