APPLICATION
NDA020243
TYPE
NDA
ORIGINAL APPROVAL
1994-12-05
LATEST ACTION
2001-09-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LUVOX · ReferenceDiscontinued
FLUVOXAMINE MALEATE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LUVOX · ReferenceDiscontinued
FLUVOXAMINE MALEATE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LUVOX · ReferenceDiscontinued
FLUVOXAMINE MALEATE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LUVOX · ReferenceDiscontinued
FLUVOXAMINE MALEATE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-09-06Labeling · Supplement 23 · standardAP
2000-08-09Labeling · Supplement 22 · standardAP
2000-06-01Labeling · Supplement 20 · standardAP
2000-06-01Labeling · Supplement 19 · standardAP
2000-06-01Labeling · Supplement 13 · standardAP
2000-06-01Labeling · Supplement 14 · standardAP
1999-10-21Manufacturing (CMC) · Supplement 18 · standardAP
1998-12-08Labeling · Supplement 15 · standardAP
1997-03-25Efficacy · Supplement 6 · standardAP
1996-12-02Manufacturing (CMC) · Supplement 8 · standardAP
1996-11-13Labeling · Supplement 9 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 7 · standardAP
1996-03-19Labeling · Supplement 5 · standardAP
1996-01-18Manufacturing (CMC) · Supplement 4 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 3 · standardAP
1995-04-12Labeling · Supplement 2 · standardAP
1995-02-21Manufacturing (CMC) · Supplement 1 · standardAP
1994-12-05Type 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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