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FDA NDA · NDA021387

PRAVIGARD PAC (COPACKAGED)

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA021387
TYPE
NDA
ORIGINAL APPROVAL
2003-06-24
LATEST ACTION
2003-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PRAVIGARD PAC (COPACKAGED)Discontinued
ASPIRIN 81MG, PRAVASTATIN SODIUM 40MG · TABLET · ORAL
PRAVIGARD PAC (COPACKAGED)Discontinued
ASPIRIN 325MG, PRAVASTATIN SODIUM 40MG · TABLET · ORAL
PRAVIGARD PAC (COPACKAGED)Discontinued
ASPIRIN 81MG, PRAVASTATIN SODIUM 80MG · TABLET · ORAL
PRAVIGARD PAC (COPACKAGED)Discontinued
ASPIRIN 81MG, PRAVASTATIN SODIUM 20MG · TABLET · ORAL
PRAVIGARD PAC (COPACKAGED)Discontinued
ASPIRIN 325MG, PRAVASTATIN SODIUM 80MG · TABLET · ORAL
PRAVIGARD PAC (COPACKAGED)Discontinued
ASPIRIN 325MG, PRAVASTATIN SODIUM 20MG · TABLET · ORAL

Approval history

2003-06-24Type 4 - New Combination · Original · standardLabelAP
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