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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

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. It is available from one supplier. 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. Forty-one 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
Pharmacology for NDA: 019898
Medical Subject Heading (MeSH) Categories for 019898
Suppliers and Packaging for NDA: 019898
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRAVACHOL pravastatin sodium TABLET;ORAL 019898 NDA E.R. Squibb & Sons, L.L.C. 0003-5178 0003-5178-05 90 TABLET in 1 BOTTLE (0003-5178-05)
PRAVACHOL pravastatin sodium TABLET;ORAL 019898 NDA E.R. Squibb & Sons, L.L.C. 0003-5194 0003-5194-10 90 TABLET in 1 BOTTLE (0003-5194-10)
Paragraph IV (Patent) Challenges for 019898
Tradename Dosage Ingredient NDA Submissiondate
PRAVACHOL TABLET;ORAL pravastatin sodium 019898 2005-06-01

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 31, 1991TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 31, 1991TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Mar 22, 1993TE:ABRLD: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 019898-004 Mar 22, 1993   Start Trial   Start Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-008 Dec 18, 2001   Start Trial   Start Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-002 Oct 31, 1991   Start Trial   Start Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-003 Oct 31, 1991   Start Trial   Start Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-004 Mar 22, 1993   Start Trial   Start Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-008 Dec 18, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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