APPLICATION
NDA017473
TYPE
NDA
ORIGINAL APPROVAL
1984-07-31
LATEST ACTION
2015-05-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORAP · ReferenceDiscontinued
PIMOZIDE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ORAP · ReferenceDiscontinued
PIMOZIDE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2015-05-11Manufacturing (CMC) · Supplement 49 · standardAP
2015-01-26Manufacturing (CMC) · Supplement 48 · standardAP
2013-08-01Manufacturing (CMC) · Supplement 47 · standardAP
2000-05-23Manufacturing (CMC) · Supplement 34 · standardAP
1999-11-12Manufacturing (CMC) · Supplement 35 · standardAP
1999-11-09Labeling · Supplement 33 · standardAP
1999-11-09Labeling · Supplement 36 · standardAP
1998-05-20Labeling · Supplement 32 · standardAP
1998-03-23Manufacturing (CMC) · Supplement 31 · standardAP
1997-10-23Manufacturing (CMC) · Supplement 30 · standardAP
1997-08-27Manufacturing (CMC) · Supplement 29 · standardAP
1997-05-30Manufacturing (CMC) · Supplement 27 · standardAP
1997-01-07Manufacturing (CMC) · Supplement 26 · standardAP
1996-07-09Manufacturing (CMC) · Supplement 24 · standardAP
1995-11-22Manufacturing (CMC) · Supplement 23 · standardAP
1995-11-22Manufacturing (CMC) · Supplement 22 · standardAP
1995-10-20Manufacturing (CMC) · Supplement 21 · standardAP
1995-05-10Manufacturing (CMC) · Supplement 19 · standardAP
1994-12-12Manufacturing (CMC) · Supplement 18 · standardAP
1994-11-02Manufacturing (CMC) · Supplement 20 · standardAP
1994-07-27Efficacy · Supplement 15AP
1994-07-27Labeling · Supplement 16AP
1990-12-21Manufacturing (CMC) · Supplement 17 · standardAP
1990-12-21Labeling · Supplement 12AP
1990-02-12Manufacturing (CMC) · Supplement 14 · standardAP
1988-12-16Manufacturing (CMC) · Supplement 13 · standardAP
1988-11-29Manufacturing (CMC) · Supplement 10 · standardAP
1988-10-27Labeling · Supplement 11AP
1987-10-07Labeling · Supplement 9AP
1987-04-20Manufacturing (CMC) · Supplement 7 · standardAP
1986-09-17Labeling · Supplement 8AP
1985-08-15Manufacturing (CMC) · Supplement 6 · standardAP
1985-03-21Labeling · Supplement 4AP
1985-03-11Labeling · Supplement 2AP
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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