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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077520

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NDA 077520 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 077520

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077520

Medical Subject Heading (MeSH) Categories for 077520

Suppliers and Packaging for NDA: 077520

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOVASTATIN lovastatin TABLET;ORAL 077520 ANDA Mutual Pharmaceutical Company, Inc. 53489-607 53489-607-05 500 TABLET in 1 BOTTLE, PLASTIC (53489-607-05)
LOVASTATIN lovastatin TABLET;ORAL 077520 ANDA Mutual Pharmaceutical Company, Inc. 53489-607 53489-607-10 1000 TABLET in 1 BOTTLE, PLASTIC (53489-607-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 14, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Apr 14, 2006TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Apr 14, 2006TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fuji
Argus Health
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Mallinckrodt
Medtronic
Johnson and Johnson
Colorcon
Boehringer Ingelheim
US Army

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