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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 019643

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NDA 019643 describes MEVACOR, which is a drug marketed by Merck and is included in one NDA. Additional details are available on the MEVACOR profile page.

The generic ingredient in MEVACOR is lovastatin. There are thirty-three drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the lovastatin profile page.

Summary for 019643

Tradename:	MEVACOR
Applicant:	Merck
Ingredient:	lovastatin
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 019643

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DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	Mar 28, 1991	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 31, 1987	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 14, 1988	TE:		RLD:	Yes

Expired US Patents for NDA 019643

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	MEVACOR	lovastatin	TABLET;ORAL	019643-004	Dec 14, 1988	⤷ Try a Trial	⤷ Try a Trial
Merck	MEVACOR	lovastatin	TABLET;ORAL	019643-002	Mar 28, 1991	⤷ Try a Trial	⤷ Try a Trial
Merck	MEVACOR	lovastatin	TABLET;ORAL	019643-003	Aug 31, 1987	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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