➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:


Last Updated: June 17, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019898

Email this page to a colleague

« Back to Dashboard

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. Thirty-six suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.
Summary for 019898
Applicant:Bristol Myers Squibb
Ingredient:pravastatin sodium
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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.