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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 075991


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NDA 075991 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 075991
Tradename:LOVASTATIN
Applicant:Carlsbad
Ingredient:lovastatin
Patents:0
Pharmacology for NDA: 075991
Medical Subject Heading (MeSH) Categories for 075991
Suppliers and Packaging for NDA: 075991
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOVASTATIN lovastatin TABLET;ORAL 075991 ANDA PD-Rx Pharmaceuticals, Inc. 43063-548 43063-548-14 14 TABLET in 1 BOTTLE, PLASTIC (43063-548-14)
LOVASTATIN lovastatin TABLET;ORAL 075991 ANDA PD-Rx Pharmaceuticals, Inc. 43063-548 43063-548-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-548-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 5, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jun 5, 2002TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jun 5, 2002TE:ABRLD:No

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