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Details for New Drug Application (NDA): 021526

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NDA 021526 describes RANEXA, which is a drug marketed by Gilead and is included in one NDA. It is available from four suppliers. There are ten patents protecting this drug. Additional details are available on the RANEXA profile page.

The generic ingredient in RANEXA is ranolazine. There are thirteen drug master file entries for this compound. Four suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the ranolazine profile page.

Summary for NDA: 021526

Tradename:
RANEXA
Applicant:
Gilead
Ingredient:
ranolazine
Patents:10
Therapeutic Class:Cardiovascular Agents
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)
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL 021526 NDA Cardinal Health 55154-4427 55154-4427-0 10 POUCH in 1 BAG (55154-4427-0) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (55154-4427-6)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1GM
Approval Date:Feb 12, 2007TE:ABRLD:Yes
Patent:6,369,062Patent Expiration:May 27, 2019Product Flag?YSubstance Flag?Delist Request?Y
Patent:6,503,911Patent Expiration:May 27, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:6,617,328Patent Expiration:May 27, 2019Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021526

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-002Jan 27, 20064,567,264► subscribe
Gilead
RANEXA
ranolazine
TABLET, EXTENDED RELEASE;ORAL021526-001Feb 12, 20074,567,264► subscribe
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