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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-one drug master file entries for this compound. Additional details are available on the aspirin; pravastatin sodium profile page.

Summary for NDA: 021387

Tradename:
PRAVIGARD PAC (COPACKAGED)
Applicant:
Bristol Myers Squibb
Ingredient:
aspirin; pravastatin sodium
Patents:0
Formulation / Manufacturing:see details

Summary 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

Summary 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

Summary 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 Orange Book 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, TABLET, TABLET;ORAL021387-003Jun 24, 20035,030,447*PED► subscribe
Bristol Myers Squibb
PRAVIGARD PAC (COPACKAGED)
aspirin; pravastatin sodium
TABLET, TABLET, TABLET;ORAL021387-002Jun 24, 20035,180,589*PED► subscribe
Bristol Myers Squibb
PRAVIGARD PAC (COPACKAGED)
aspirin; pravastatin sodium
TABLET, TABLET, TABLET;ORAL021387-002Jun 24, 20035,622,985*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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