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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075451

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NDA 075451 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-one 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 075451
Tradename:LOVASTATIN
Applicant:Mylan
Ingredient:lovastatin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075451
Medical Subject Heading (MeSH) Categories for 075451
Suppliers and Packaging for NDA: 075451
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOVASTATIN lovastatin TABLET;ORAL 075451 ANDA Mylan Pharmaceuticals Inc. 0378-6510 N 0378-6510-91
LOVASTATIN lovastatin TABLET;ORAL 075451 ANDA Mylan Pharmaceuticals Inc. 0378-6520 N 0378-6520-91

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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