APPLICATION
ANDA072429
TYPE
ANDA
ORIGINAL APPROVAL
1988-07-19
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FENOPROFEN CALCIUMDiscontinued
FENOPROFEN CALCIUM EQ 600MG BASE · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 9 · standardAP
2021-04-28Labeling · Supplement 8 · standardAP
1994-04-21Manufacturing (CMC) · Supplement 5AP
1991-05-31Labeling · Supplement 7AP
1989-09-07Bioequivalence · Supplement 6AP
1989-05-12Labeling · Supplement 4AP
1989-03-31Labeling · Supplement 3AP
1988-07-19OriginalAP
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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