APPLICATION
NDA020210
TYPE
NDA
ORIGINAL APPROVAL
1993-07-29
LATEST ACTION
2000-03-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROPULSIDDiscontinued
CISAPRIDE MONOHYDRATE EQ 10MG BASE · TABLET · ORAL
PROPULSIDDiscontinued
CISAPRIDE MONOHYDRATE EQ 20MG BASE · TABLET · ORAL
Approval history
1999-11-10Manufacturing (CMC) · Supplement 29 · standardAP
1999-04-20Manufacturing (CMC) · Supplement 28 · standardAP
1999-01-12Manufacturing (CMC) · Supplement 27 · standardAP
1998-10-06Manufacturing (CMC) · Supplement 24 · standardAP
1998-09-22Manufacturing (CMC) · Supplement 22 · standardAP
1998-08-17Labeling · Supplement 26 · standardAP
1998-07-31Labeling · Supplement 25 · standardAP
1998-06-26Manufacturing (CMC) · Supplement 20 · standardAP
1998-06-16Manufacturing (CMC) · Supplement 23 · standardAP
1998-06-02Manufacturing (CMC) · Supplement 19 · standardAP
1997-11-07Labeling · Supplement 17 · standardAP
1997-01-29Manufacturing (CMC) · Supplement 14 · standardAP
1996-10-15Manufacturing (CMC) · Supplement 12 · standardAP
1996-09-18Manufacturing (CMC) · Supplement 13 · standardAP
1995-12-11Labeling · Supplement 11 · standardAP
1995-10-03Manufacturing (CMC) · Supplement 8 · standardAP
1995-09-15Labeling · Supplement 7 · standardAP
1994-10-11Manufacturing (CMC) · Supplement 6 · standardAP
1994-07-06Manufacturing (CMC) · Supplement 5 · standardAP
1994-03-07Manufacturing (CMC) · Supplement 4 · standardAP
1993-12-23Labeling · Supplement 3 · standardAP
1993-12-03Manufacturing (CMC) · Supplement 1 · standardAP
1993-09-27Labeling · Supplement 2 · 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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