Documents
Application Sponsors
Marketing Status
Application Products
001 | SUSPENSION;ORAL | EQ 1MG BASE/ML | 0 | PROPULSID | CISAPRIDE MONOHYDRATE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1995-09-15 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 1995-12-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1997-01-31 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1997-10-28 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 1997-11-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-08-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-06-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1998-09-22 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 1998-07-31 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 1998-08-17 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1999-01-12 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1999-02-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1999-03-24 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1999-11-10 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2000-03-06 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 2000-03-06 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 20398
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"PROPULSID","activeIngredients":"CISAPRIDE MONOHYDRATE","strength":"EQ 1MG BASE\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROPULSID","submission":"CISAPRIDE MONOHYDRATE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)