Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022406

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XARELTO (RIVAROXABAN)
10MG Marketing Status: Prescription

Active Ingredient: RIVAROXABAN
Proprietary Name: XARELTO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022406
Product Number: 001
Approval Date: Jul 1, 2011
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XARELTO (RIVAROXABAN)
15MG Marketing Status: Prescription

Active Ingredient: RIVAROXABAN
Proprietary Name: XARELTO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022406
Product Number: 002
Approval Date: Nov 4, 2011
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XARELTO (RIVAROXABAN)
20MG Marketing Status: Prescription

Active Ingredient: RIVAROXABAN
Proprietary Name: XARELTO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022406
Product Number: 003
Approval Date: Nov 4, 2011
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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