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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 078296


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NDA 078296 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-two 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-three suppliers are listed for this compound. Additional details are available on the lovastatin profile page.
Summary for 078296
Tradename:LOVASTATIN
Applicant:Lupin
Ingredient:lovastatin
Patents:0
Pharmacology for NDA: 078296
Medical Subject Heading (MeSH) Categories for 078296
Suppliers and Packaging for NDA: 078296
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOVASTATIN lovastatin TABLET;ORAL 078296 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8151 0615-8151-39 30 TABLET in 1 BLISTER PACK (0615-8151-39)
LOVASTATIN lovastatin TABLET;ORAL 078296 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8152 0615-8152-39 30 TABLET in 1 BLISTER PACK (0615-8152-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 14, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 1, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Nov 1, 2007TE:ABRLD:No

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