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Last Updated: April 28, 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-four 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021316

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Medical Subject Heading (MeSH) Categories for 021316

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

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:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Jun 26, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	Jun 26, 2002	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	40MG
Approval Date:	Jun 26, 2002	TE:		RLD:	Yes

Expired US Patents for NDA 021316

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

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