APPLICATION
ANDA072395
TYPE
ANDA
ORIGINAL APPROVAL
1988-10-14
LATEST ACTION
1995-04-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
FENOPROFEN CALCIUMDiscontinued
FENOPROFEN CALCIUM EQ 300MG BASE · CAPSULE · ORAL
Approval history
1995-04-18Manufacturing (CMC) · Supplement 7AP
1991-07-30Labeling · Supplement 6AP
1989-03-31Labeling · Supplement 2AP
1989-02-27Bioequivalence · Supplement 4AP
1988-10-14OriginalAP
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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