APPLICATION
ANDA072602
TYPE
ANDA
ORIGINAL APPROVAL
1988-10-11
LATEST ACTION
2016-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FENOPROFEN CALCIUMDiscontinued
FENOPROFEN CALCIUM EQ 600MG BASE · TABLET · ORAL
Approval history
2016-05-09Labeling · Supplement 7 · standardAP
2016-02-29Labeling · Supplement 8 · standardAP
1991-08-02Labeling · Supplement 5AP
1991-05-31Manufacturing (CMC) · Supplement 3AP
1990-11-19Manufacturing (CMC) · Supplement 4AP
1990-06-29Manufacturing (CMC) · Supplement 2AP
1989-03-31Labeling · Supplement 1AP
1988-10-11OriginalAP
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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