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Last Updated: December 15, 2025

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

Tradename:	PRAVIGARD PAC (COPACKAGED)
Applicant:	Bristol Myers Squibb
Ingredient:	aspirin; pravastatin sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	81MG;20MG
Approval Date:	Jun 24, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	81MG;40MG
Approval Date:	Jun 24, 2003	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	81MG;80MG
Approval Date:	Jun 24, 2003	TE:		RLD:	No

Expired US Patents for NDA 021387

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-006	Jun 24, 2003	⤷ Get Started Free	⤷ Get Started Free
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-003	Jun 24, 2003	⤷ Get Started Free	⤷ Get Started Free
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-005	Jun 24, 2003	⤷ Get Started Free	⤷ Get Started Free
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-006	Jun 24, 2003	⤷ Get Started Free	⤷ Get Started Free
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-004	Jun 24, 2003	⤷ Get Started Free	⤷ Get Started Free
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-002	Jun 24, 2003	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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