APPLICATION
NDA020398
TYPE
NDA
ORIGINAL APPROVAL
1995-09-15
LATEST ACTION
2000-03-06
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
PROPULSIDDiscontinued
CISAPRIDE MONOHYDRATE EQ 1MG BASE/ML · SUSPENSION · ORAL
Approval history
1999-11-10Manufacturing (CMC) · Supplement 19 · standardAP
1999-03-24Manufacturing (CMC) · Supplement 18 · standardAP
1999-02-08Manufacturing (CMC) · Supplement 17 · standardAP
1999-01-12Manufacturing (CMC) · Supplement 16 · standardAP
1998-09-22Manufacturing (CMC) · Supplement 13 · standardAP
1998-08-17Labeling · Supplement 15 · standardAP
1998-08-06Manufacturing (CMC) · Supplement 10 · standardAP
1998-07-31Labeling · Supplement 14 · standardAP
1998-06-26Manufacturing (CMC) · Supplement 11 · standardAP
1997-11-07Labeling · Supplement 8 · standardAP
1997-10-28Manufacturing (CMC) · Supplement 6 · standardAP
1997-01-31Manufacturing (CMC) · Supplement 4 · standardAP
1995-12-11Labeling · Supplement 2 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 1 · standardAP
1995-09-15Type 3 - New Dosage Form · 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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