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. Forty 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

Medical Subject Heading (MeSH) Categories for 019898

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 31, 1991	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 31, 1991	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 22, 1993	TE:		RLD:	Yes

Expired US Patents for NDA 019898

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-003	Oct 31, 1991	5,180,589*PED	⤷ Subscribe
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-008	Dec 18, 2001	5,622,985*PED	⤷ Subscribe
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-002	Oct 31, 1991	4,346,227*PED	⤷ Subscribe
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-004	Mar 22, 1993	5,180,589*PED	⤷ Subscribe
Bristol Myers Squibb	PRAVACHOL	pravastatin sodium	TABLET;ORAL	019898-004	Mar 22, 1993	5,030,447*PED	⤷ Subscribe
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