Documents
Application Sponsors
| NDA 019915 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 002 | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MONOPRIL | FOSINOPRIL SODIUM |
| 003 | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MONOPRIL | FOSINOPRIL SODIUM |
| 004 | TABLET;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | MONOPRIL | FOSINOPRIL SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1991-05-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1991-06-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1991-09-09 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1992-06-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1992-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1992-07-10 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1992-10-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1993-04-05 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 1995-05-02 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1994-05-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1994-06-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-12-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1995-03-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1995-02-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1994-12-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1995-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 1996-07-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1995-09-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1996-03-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1996-08-02 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1997-01-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1997-01-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1997-02-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1997-09-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1997-10-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1998-01-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1998-08-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1999-03-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1999-05-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1999-05-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1999-11-16 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2002-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2000-06-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2000-09-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 37 | AP | 2003-05-27 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2003-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2009-02-09 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 42 | Null | 0 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 19915
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"MONOPRIL","activeIngredients":"FOSINOPRIL SODIUM","strength":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MONOPRIL","activeIngredients":"FOSINOPRIL SODIUM","strength":"20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"MONOPRIL","activeIngredients":"FOSINOPRIL SODIUM","strength":"40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"05\/27\/2003","submission":"SUPPL-37","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19915se5-037_monopril_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MONOPRIL","submission":"FOSINOPRIL SODIUM","actionType":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MONOPRIL","submission":"FOSINOPRIL SODIUM","actionType":"20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"MONOPRIL","submission":"FOSINOPRIL SODIUM","actionType":"40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2003-05-27
)
)