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FDA NDA · NDA020767

PROPULSID QUICKSOLV

Sponsor: JANSSEN PHARMA

APPLICATION
NDA020767
TYPE
NDA
ORIGINAL APPROVAL
1997-11-07
LATEST ACTION
2000-03-06
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

PROPULSID QUICKSOLVDiscontinued
CISAPRIDE MONOHYDRATE EQ 20MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2000-03-06Labeling · Supplement 11 · standard — Review ↗AP
2000-03-06Labeling · Supplement 9 · standard — Review ↗AP
1999-11-10Manufacturing (CMC) · Supplement 8 · standardAP
1999-04-20Manufacturing (CMC) · Supplement 7 · standardAP
1999-01-12Manufacturing (CMC) · Supplement 6 · standardAP
1998-09-22Manufacturing (CMC) · Supplement 3 · standardAP
1998-08-17Labeling · Supplement 5 · standardAP
1998-07-31Labeling · Supplement 4 · standardAP
1998-06-26Manufacturing (CMC) · Supplement 1 · standardAP
1997-11-07Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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