NDA 021387

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #021387

Documents

• Letter: 2003-07-06
• Review: 2004-01-29
• Label: 2003-07-08

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

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(
    [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
        )

)