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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 019898


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NDA 019898 describes PRAVACHOL, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. Additional details are available on the PRAVACHOL profile page.

The generic ingredient in PRAVACHOL is pravastatin sodium. There are sixteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 019898
Tradename:PRAVACHOL
Applicant:Bristol Myers Squibb
Ingredient:pravastatin sodium
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019898

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 31, 1991TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 31, 1991TE:RLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Mar 22, 1993TE:RLD:Yes

Expired US Patents for NDA 019898

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