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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. It is available from one supplier. 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. Forty-one suppliers are listed for this compound. Additional details are available on the lovastatin profile page.

Summary for NDA: 019643

Tradename:
MEVACOR
Applicant:
Merck
Ingredient:
lovastatin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019643

Suppliers and Packaging for NDA: 019643

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEVACOR
lovastatin
TABLET;ORAL 019643 NDA Merck Sharp & Dohme Corp. 0006-0731 0006-0731-61 60 TABLET in 1 BOTTLE (0006-0731-61)
MEVACOR
lovastatin
TABLET;ORAL 019643 NDA Merck Sharp & Dohme Corp. 0006-0732 0006-0732-61 60 TABLET in 1 BOTTLE (0006-0732-61)

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Mar 28, 1991TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG **Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 31, 1987TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG **Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 14, 1988TE:RLD:No

Expired Orange Book Patents for NDA: 019643

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
MEVACOR
lovastatin
TABLET;ORAL019643-002Mar 28, 19914,231,938*PED► subscribe
Merck
MEVACOR
lovastatin
TABLET;ORAL019643-004Dec 14, 19884,231,938*PED► subscribe
Merck
MEVACOR
lovastatin
TABLET;ORAL019643-003Aug 31, 19874,231,938*PED► subscribe
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