Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021316

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NDA 021316 describes ALTOPREV, which is a drug marketed by Azurity and is included in one NDA. Additional details are available on the ALTOPREV profile page.

The generic ingredient in ALTOPREV is lovastatin. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the lovastatin profile page.

Summary for 021316

Tradename:	ALTOPREV
Applicant:	Azurity
Ingredient:	lovastatin
Patents:	0

Medical Subject Heading (MeSH) Categories for 021316

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

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:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	Jun 26, 2002	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	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
Azurity	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-001	Jun 26, 2002	⤷ Start Trial	⤷ Start Trial
Azurity	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-003	Jun 26, 2002	⤷ Start Trial	⤷ Start Trial
Azurity	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-003	Jun 26, 2002	⤷ Start Trial	⤷ Start Trial
Azurity	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-003	Jun 26, 2002	⤷ Start Trial	⤷ Start Trial
Azurity	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-002	Jun 26, 2002	⤷ Start Trial	⤷ Start Trial
Azurity	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-001	Jun 26, 2002	⤷ Start Trial	⤷ Start Trial
Azurity	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-002	Jun 26, 2002	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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