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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 075300


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NDA 075300 describes LOVASTATIN, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Corepharma, Epic Pharma Llc, Lupin, Sun Pharm Industries, and Teva, and is included in ten NDAs. It is available from twenty-three suppliers. Additional details are available on the LOVASTATIN profile page.

The generic ingredient in LOVASTATIN 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 075300
Tradename:LOVASTATIN
Applicant:Chartwell Rx
Ingredient:lovastatin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075300

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 17, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 17, 2001TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Dec 17, 2001TE:ABRLD:No

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