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Last Updated: March 29, 2024

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. It is available from one supplier. 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-six 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
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021526
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANEXA ranolazine TABLET, EXTENDED RELEASE;ORAL 021526 NDA Aphena Pharma Solutions - Tennessee, LLC 43353-880 43353-880-83 3600 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-880-83)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Feb 12, 2007TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Jan 27, 2006TE:RLD:Yes

Expired US Patents for NDA 021526

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

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