Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202192

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JAKAFI (RUXOLITINIB PHOSPHATE)
EQ 5MG BASE
Marketing Status: Prescription

Active Ingredient: RUXOLITINIB PHOSPHATE
Proprietary Name: JAKAFI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202192
Product Number: 001
Approval Date: Nov 16, 2011
Applicant Holder Full Name: INCYTE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

JAKAFI (RUXOLITINIB PHOSPHATE)
EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: RUXOLITINIB PHOSPHATE
Proprietary Name: JAKAFI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202192
Product Number: 002
Approval Date: Nov 16, 2011
Applicant Holder Full Name: INCYTE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

JAKAFI (RUXOLITINIB PHOSPHATE)
EQ 15MG BASE
Marketing Status: Prescription

Active Ingredient: RUXOLITINIB PHOSPHATE
Proprietary Name: JAKAFI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202192
Product Number: 003
Approval Date: Nov 16, 2011
Applicant Holder Full Name: INCYTE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

JAKAFI (RUXOLITINIB PHOSPHATE)
EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: RUXOLITINIB PHOSPHATE
Proprietary Name: JAKAFI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202192
Product Number: 004
Approval Date: Nov 16, 2011
Applicant Holder Full Name: INCYTE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

JAKAFI (RUXOLITINIB PHOSPHATE)
EQ 25MG BASE
Marketing Status: Prescription

Active Ingredient: RUXOLITINIB PHOSPHATE
Proprietary Name: JAKAFI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202192
Product Number: 005
Approval Date: Nov 16, 2011
Applicant Holder Full Name: INCYTE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information