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Generated: December 12, 2018

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Details for New Drug Application (NDA): 021387

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NDA 021387 describes PRAVIGARD PAC (COPACKAGED), which is a drug marketed by Bristol Myers Squibb and is included in one NDA. Additional details are available on the PRAVIGARD PAC (COPACKAGED) profile page.

The generic ingredient in PRAVIGARD PAC (COPACKAGED) is aspirin; pravastatin sodium. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; pravastatin sodium profile page.
Summary for 021387

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, TABLET, TABLET;ORALStrength81MG,N/A;N/A,20MG
Approval Date:Jun 24, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, TABLET, TABLET;ORALStrength81MG,N/A;N/A,40MG
Approval Date:Jun 24, 2003TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, TABLET, TABLET;ORALStrength81MG,N/A;N/A,80MG
Approval Date:Jun 24, 2003TE:RLD:No

Expired US Patents for NDA 021387

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb PRAVIGARD PAC (COPACKAGED) aspirin; pravastatin sodium TABLET, TABLET, TABLET;ORAL 021387-005 Jun 24, 2003 ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb PRAVIGARD PAC (COPACKAGED) aspirin; pravastatin sodium TABLET, TABLET, TABLET;ORAL 021387-005 Jun 24, 2003 ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb PRAVIGARD PAC (COPACKAGED) aspirin; pravastatin sodium TABLET, TABLET, TABLET;ORAL 021387-002 Jun 24, 2003 ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb PRAVIGARD PAC (COPACKAGED) aspirin; pravastatin sodium TABLET, TABLET;ORAL 021387-006 Jun 24, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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