Documents
Application Sponsors
NDA 021387 | BRISTOL MYERS SQUIBB | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Discontinued | 005 |
Discontinued | 006 |
Application Products
001 | TABLET, TABLET, TABLET;ORAL | 81MG,N/A;N/A,20MG | 0 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM |
002 | TABLET, TABLET, TABLET;ORAL | 81MG,N/A;N/A,40MG | 0 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM |
003 | TABLET, TABLET, TABLET;ORAL | 81MG,N/A;N/A,80MG | 0 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM |
004 | TABLET, TABLET, TABLET;ORAL | 325MG,N/A;N/A,20MG | 0 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM |
005 | TABLET, TABLET, TABLET;ORAL | 325MG,N/A;N/A,40MG | 0 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM |
006 | TABLET, TABLET;ORAL | 325MG,N/A;N/A,80MG | 0 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2003-06-24 | STANDARD |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 21387
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"PRAVIGARD PAC (COPACKAGED)","activeIngredients":"ASPIRIN; PRAVASTATIN SODIUM","strength":"81MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRAVIGARD PAC (COPACKAGED)","activeIngredients":"ASPIRIN; PRAVASTATIN SODIUM","strength":"81MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRAVIGARD PAC (COPACKAGED)","activeIngredients":"ASPIRIN; PRAVASTATIN SODIUM","strength":"81MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRAVIGARD PAC (COPACKAGED)","activeIngredients":"ASPIRIN; PRAVASTATIN SODIUM","strength":"325MG;20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRAVIGARD PAC (COPACKAGED)","activeIngredients":"ASPIRIN; PRAVASTATIN SODIUM","strength":"325MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRAVIGARD PAC (COPACKAGED)","activeIngredients":"ASPIRIN; PRAVASTATIN SODIUM","strength":"325MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/24\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21387_pravigard_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"PRAVIGARD PAC (COPACKAGED)","submission":"ASPIRIN; PRAVASTATIN SODIUM","actionType":"81MG;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRAVIGARD PAC (COPACKAGED)","submission":"ASPIRIN; PRAVASTATIN SODIUM","actionType":"81MG;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRAVIGARD PAC (COPACKAGED)","submission":"ASPIRIN; PRAVASTATIN SODIUM","actionType":"81MG;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRAVIGARD PAC (COPACKAGED)","submission":"ASPIRIN; PRAVASTATIN SODIUM","actionType":"325MG;20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRAVIGARD PAC (COPACKAGED)","submission":"ASPIRIN; PRAVASTATIN SODIUM","actionType":"325MG;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRAVIGARD PAC (COPACKAGED)","submission":"ASPIRIN; PRAVASTATIN SODIUM","actionType":"325MG;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2003-06-24
)
)