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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019898

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PRAVACHOL (PRAVASTATIN SODIUM)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PRAVASTATIN SODIUM
Proprietary Name: PRAVACHOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019898
Product Number: 002
Approval Date: Oct 31, 1991
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAVACHOL (PRAVASTATIN SODIUM)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PRAVASTATIN SODIUM
Proprietary Name: PRAVACHOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019898
Product Number: 003
Approval Date: Oct 31, 1991
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAVACHOL (PRAVASTATIN SODIUM)
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PRAVASTATIN SODIUM
Proprietary Name: PRAVACHOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019898
Product Number: 004
Approval Date: Mar 22, 1993
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAVACHOL (PRAVASTATIN SODIUM)
80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PRAVASTATIN SODIUM
Proprietary Name: PRAVACHOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019898
Product Number: 008
Approval Date: Dec 18, 2001
Applicant Holder Full Name: BRISTOL MYERS SQUIBB
Marketing Status:  Discontinued
Patent and Exclusivity Information
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