Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 10MG BASE | 0 | PROPULSID | CISAPRIDE MONOHYDRATE |
| 002 | TABLET;ORAL | EQ 20MG BASE | 0 | PROPULSID | CISAPRIDE MONOHYDRATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1993-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1993-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1993-12-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1994-03-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-07-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1994-10-11 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1995-09-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-10-03 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1995-12-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-10-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-09-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1997-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 1997-11-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1998-06-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1998-06-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1998-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1998-06-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1998-10-06 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 1998-07-31 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 1998-08-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1999-01-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1999-04-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1999-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2000-03-06 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2000-03-06 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 20210
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/Propulsid.pdf"]
[products] => [{"drugName":"PROPULSID","activeIngredients":"CISAPRIDE MONOHYDRATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROPULSID","activeIngredients":"CISAPRIDE MONOHYDRATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROPULSID","submission":"CISAPRIDE MONOHYDRATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROPULSID","submission":"CISAPRIDE MONOHYDRATE","actionType":"EQ 20MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)