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Details for New Drug Application (NDA): 021316

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NDA 021316 describes ALTOPREV, which is a drug marketed by Covis Pharma Sarl and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the ALTOPREV profile page.

The generic ingredient in ALTOPREV is lovastatin. There are thirty-three drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the lovastatin profile page.

Summary for NDA: 021316

Tradename:
ALTOPREV
Applicant:
Covis Pharma Sarl
Ingredient:
lovastatin
Patents:3
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021316

Suppliers and Packaging for NDA: 021316

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALTOPREV
lovastatin
TABLET, EXTENDED RELEASE;ORAL 021316 NDA Shionogi Inc. 59630-628 59630-628-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59630-628-30)
ALTOPREV
lovastatin
TABLET, EXTENDED RELEASE;ORAL 021316 NDA Shionogi Inc. 59630-629 59630-629-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59630-629-30)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jun 26, 2002TE:RLD:No
Patent:5,916,595Patent Expiration:Dec 12, 2017Product Flag?Substance Flag?Delist Request?
Patent:6,485,748Patent Expiration:Dec 12, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:6,080,778Patent Expiration:Mar 23, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF DECREASING THE PRODUCTION OF A-BETA USING A COMPOSITION WHICH DECREASES BLOOD CHOLESTEROL IN PATIENTS AT RISK OF OR EXHIBITING SYMPTOMS OF ALZHEIMER'S DISEASE


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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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