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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
US Army
US Department of Justice
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Farmers Insurance

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078296

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NDA 078296 describes LOVASTATIN, which is a drug marketed by Actavis Elizabeth, Apotex Inc, Carlsbad, Lupin, Mylan, Sandoz, Sun Pharm Industries, and Teva, and is included in ten NDAs. It is available from forty 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. Forty-two suppliers are listed for this compound. Additional details are available on the lovastatin profile page.

Summary for 078296

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

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 STAT Rx USA LLC 16590-311 16590-311-90 90 TABLET in 1 BOTTLE, PLASTIC (16590-311-90)
LOVASTATIN lovastatin TABLET;ORAL 078296 ANDA STAT Rx USA LLC 16590-311 16590-311-60 60 TABLET in 1 BOTTLE, PLASTIC (16590-311-60)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Queensland Health
Harvard Business School
Cantor Fitzgerald

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