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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021387

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PRAVIGARD PAC (COPACKAGED) (ASPIRIN; PRAVASTATIN SODIUM)
81MG;20MG
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; PRAVASTATIN SODIUM
Proprietary Name: PRAVIGARD PAC (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 81MG;20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021387
Product Number: 001
Approval Date: Jun 24, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAVIGARD PAC (COPACKAGED) (ASPIRIN; PRAVASTATIN SODIUM)
81MG;40MG
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; PRAVASTATIN SODIUM
Proprietary Name: PRAVIGARD PAC (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 81MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021387
Product Number: 002
Approval Date: Jun 24, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAVIGARD PAC (COPACKAGED) (ASPIRIN; PRAVASTATIN SODIUM)
81MG;80MG
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; PRAVASTATIN SODIUM
Proprietary Name: PRAVIGARD PAC (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 81MG;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021387
Product Number: 003
Approval Date: Jun 24, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAVIGARD PAC (COPACKAGED) (ASPIRIN; PRAVASTATIN SODIUM)
325MG;20MG
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; PRAVASTATIN SODIUM
Proprietary Name: PRAVIGARD PAC (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021387
Product Number: 004
Approval Date: Jun 24, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAVIGARD PAC (COPACKAGED) (ASPIRIN; PRAVASTATIN SODIUM)
325MG;40MG
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; PRAVASTATIN SODIUM
Proprietary Name: PRAVIGARD PAC (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021387
Product Number: 005
Approval Date: Jun 24, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAVIGARD PAC (COPACKAGED) (ASPIRIN; PRAVASTATIN SODIUM)
325MG;80MG
Marketing Status: Discontinued
Active Ingredient: ASPIRIN; PRAVASTATIN SODIUM
Proprietary Name: PRAVIGARD PAC (COPACKAGED)
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 325MG;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021387
Product Number: 006
Approval Date: Jun 24, 2003
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
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