APPLICATION
NDA019583
TYPE
NDA
ORIGINAL APPROVAL
1991-12-24
LATEST ACTION
2006-01-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RELAFEN · ReferenceDiscontinued
NABUMETONE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
RELAFEN · ReferenceDiscontinued
NABUMETONE 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-10-11Labeling · Supplement 19 · standardAP
2001-06-14Manufacturing (CMC) · Supplement 20 · standardAP
1999-08-02Manufacturing (CMC) · Supplement 18 · standardAP
1998-02-03Manufacturing (CMC) · Supplement 16 · standardAP
1996-07-24Manufacturing (CMC) · Supplement 15 · standardAP
1996-06-18Manufacturing (CMC) · Supplement 14 · standardAP
1995-07-14Manufacturing (CMC) · Supplement 13 · standardAP
1995-05-10Manufacturing (CMC) · Supplement 12 · standardAP
1995-01-04Manufacturing (CMC) · Supplement 11 · standardAP
1994-10-26Manufacturing (CMC) · Supplement 10 · standardAP
1994-09-22Manufacturing (CMC) · Supplement 9 · standardAP
1993-11-23Labeling · Supplement 4 · standardAP
1993-11-23Labeling · Supplement 5 · standardAP
1993-01-25Manufacturing (CMC) · Supplement 3 · standardAP
1991-12-24Type 1 - New Molecular Entity · 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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