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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

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
TABLET;ORAL 019643 NDA Merck Sharp & Dohme Corp. 0006-0731 0006-0731-61 60 TABLET in 1 BOTTLE (0006-0731-61)
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Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG **Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons**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Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG **Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons**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
TABLET;ORAL019643-002Mar 28, 19914,231,938*PED► subscribe
TABLET;ORAL019643-004Dec 14, 19884,231,938*PED► subscribe
TABLET;ORAL019643-003Aug 31, 19874,231,938*PED► subscribe
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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 verifification 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.