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Last Updated: February 28, 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-six 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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-008 Dec 18, 2001 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-003 Oct 31, 1991 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-002 Oct 31, 1991 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-002 Oct 31, 1991 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-008 Dec 18, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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