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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021526

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RANEXA (RANOLAZINE)
500MG
Marketing Status: Discontinued
Active Ingredient: RANOLAZINE
Proprietary Name: RANEXA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021526
Product Number: 002
Approval Date: Jan 27, 2006
Applicant Holder Full Name: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
Marketing Status:  Discontinued
Patent and Exclusivity Information
RANEXA (RANOLAZINE)
1GM
Marketing Status: Discontinued
Active Ingredient: RANOLAZINE
Proprietary Name: RANEXA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021526
Product Number: 001
Approval Date: Feb 12, 2007
Applicant Holder Full Name: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
Marketing Status:  Discontinued
Patent and Exclusivity Information
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