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FDA ANDA · ANDA072396

FENOPROFEN CALCIUM

Sponsor: RISING

APPLICATION
ANDA072396
TYPE
ANDA
ORIGINAL APPROVAL
1988-10-17
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 8 · standardAP
1995-04-18Manufacturing (CMC) · Supplement 7AP
1991-07-30Labeling · Supplement 6AP
1989-03-31Labeling · Supplement 2AP
1989-02-27Bioequivalence · Supplement 5AP
1989-02-27Bioequivalence · Supplement 3AP
1988-10-17OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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