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Fish and Richardson
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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

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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
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Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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