APPLICATION
ANDA072407
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-13
LATEST ACTION
2016-05-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FENOPROFEN CALCIUMDiscontinued
FENOPROFEN CALCIUM EQ 600MG BASE · TABLET · ORAL
Approval history
2016-05-11Labeling · Supplement 11 · standardAP
2016-05-09Labeling · Supplement 10 · standardAP
1997-01-31Manufacturing (CMC) · Supplement 9AP
1991-05-07Labeling · Supplement 8AP
1989-07-12Manufacturing (CMC) · Supplement 3AP
1989-07-11Manufacturing (CMC) · Supplement 2AP
1989-07-11Manufacturing (CMC) · Supplement 4AP
1989-05-24Bioequivalence · Supplement 6AP
1989-04-21Labeling · Supplement 5AP
1989-03-31Labeling · Supplement 1AP
1988-06-13OriginalAP
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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