APPLICATION
NDA018554
TYPE
NDA
ORIGINAL APPROVAL
1989-01-27
LATEST ACTION
2001-07-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
EULEXIN · ReferenceDiscontinued
FLUTAMIDE 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2001-03-14Manufacturing (CMC) · Supplement 20 · priorityAP
2001-01-23Manufacturing (CMC) · Supplement 19 · priorityAP
2000-01-07Manufacturing (CMC) · Supplement 18 · priorityAP
1999-08-19Labeling · Supplement 15 · standardAP
1998-05-18Manufacturing (CMC) · Supplement 17 · priorityAP
1997-11-12Manufacturing (CMC) · Supplement 16 · priorityAP
1996-08-30Manufacturing (CMC) · Supplement 4 · priorityAP
1996-06-21Efficacy · Supplement 14 · standardAP
1995-11-15Manufacturing (CMC) · Supplement 13 · priorityAP
1995-09-15Labeling · Supplement 12 · standardAP
1994-10-26Labeling · Supplement 11 · standardAP
1993-07-22Manufacturing (CMC) · Supplement 8 · priorityAP
1992-07-29Manufacturing (CMC) · Supplement 2 · priorityAP
1992-05-18Manufacturing (CMC) · Supplement 9 · priorityAP
1991-09-19Labeling · Supplement 10AP
1991-05-07Manufacturing (CMC) · Supplement 5 · priorityAP
1990-09-03Labeling · Supplement 3AP
1989-10-17Labeling · Supplement 1AP
1989-01-27Type 1 - New Molecular Entity · Original · priorityAP
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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