APPLICATION
NDA017710
TYPE
NDA
ORIGINAL APPROVAL
1977-06-09
LATEST ACTION
1997-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NALFON · ReferenceDiscontinued
FENOPROFEN CALCIUM EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1997-12-22Manufacturing (CMC) · Supplement 26 · standardAP
1995-03-29Labeling · Supplement 21 · standardAP
1994-04-25Manufacturing (CMC) · Supplement 23 · standardAP
1988-03-04Manufacturing (CMC) · Supplement 14 · standardAP
1988-02-08Manufacturing (CMC) · Supplement 13 · standardAP
1987-12-11Manufacturing (CMC) · Supplement 9 · standardAP
1987-07-08Manufacturing (CMC) · Supplement 15 · standardAP
1987-07-08Manufacturing (CMC) · Supplement 11 · standardAP
1986-06-09Labeling · Supplement 12 · standardAP
1983-08-09Labeling · Supplement 7 · standardAP
1983-08-09Labeling · Supplement 4 · standardAP
1983-03-31Labeling · Supplement 10 · standardAP
1982-02-10Manufacturing (CMC) · Supplement 5 · standardAP
1982-02-10Manufacturing (CMC) · Supplement 6 · standardAP
1980-04-09Manufacturing (CMC) · Supplement 3 · standardAP
1977-06-09Type 3 - New Dosage Form · Original · standardAP
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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