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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 021316


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NDA 021316 describes ALTOPREV, which is a drug marketed by Covis and is included in one NDA. It is available from one supplier. 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. Twenty-three suppliers are listed for this compound. Additional details are available on the lovastatin profile page.
Summary for 021316
Tradename:ALTOPREV
Applicant:Covis
Ingredient:lovastatin
Patents:0
Pharmacology for NDA: 021316
Medical Subject Heading (MeSH) Categories for 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 Covis Pharma US, Inc 70515-628 70515-628-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70515-628-30)
ALTOPREV lovastatin TABLET, EXTENDED RELEASE;ORAL 021316 NDA Covis Pharma US, Inc 70515-629 70515-629-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70515-629-30)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jun 26, 2002TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jun 26, 2002TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Jun 26, 2002TE:RLD:Yes

Expired US Patents for NDA 021316

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Covis ALTOPREV lovastatin TABLET, EXTENDED RELEASE;ORAL 021316-004 Jun 26, 2002 ⤷  Sign Up ⤷  Sign Up
Covis ALTOPREV lovastatin TABLET, EXTENDED RELEASE;ORAL 021316-001 Jun 26, 2002 ⤷  Sign Up ⤷  Sign Up
Covis ALTOPREV lovastatin TABLET, EXTENDED RELEASE;ORAL 021316-002 Jun 26, 2002 ⤷  Sign Up ⤷  Sign Up
Covis ALTOPREV lovastatin TABLET, EXTENDED RELEASE;ORAL 021316-002 Jun 26, 2002 ⤷  Sign Up ⤷  Sign Up
Covis ALTOPREV lovastatin TABLET, EXTENDED RELEASE;ORAL 021316-003 Jun 26, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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