APPLICATION
ANDA072438
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-22
LATEST ACTION
1991-05-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FENOPROFEN CALCIUMDiscontinued
FENOPROFEN CALCIUM EQ 300MG BASE · CAPSULE · ORAL
Approval history
1991-05-31Labeling · Supplement 5AP
1989-05-12Labeling · Supplement 4AP
1989-03-31Labeling · Supplement 3AP
1988-08-22OriginalAP
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.