Last Updated: May 3, 2026

Details for New Drug Application (NDA): 021526

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NDA 021526 describes RANEXA, which is a drug marketed by Menarini Intl and is included in one NDA. Additional details are available on the RANEXA profile page.

The generic ingredient in RANEXA is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ranolazine profile page.

Summary for 021526

Tradename:	RANEXA
Applicant:	Menarini Intl
Ingredient:	ranolazine
Patents:	0

Medical Subject Heading (MeSH) Categories for 021526

Cardiovascular Agents
Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 12, 2007	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 27, 2006	TE:		RLD:	Yes

Expired US Patents for NDA 021526

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006	⤷ Start Trial	⤷ Start Trial
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007	⤷ Start Trial	⤷ Start Trial
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006	⤷ Start Trial	⤷ Start Trial
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007	⤷ Start Trial	⤷ Start Trial
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006	⤷ Start Trial	⤷ Start Trial
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007	⤷ Start Trial	⤷ Start Trial
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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