Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022075

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NOURIANZ (ISTRADEFYLLINE)
20MG
Marketing Status: Prescription

Active Ingredient: ISTRADEFYLLINE
Proprietary Name: NOURIANZ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022075
Product Number: 001
Approval Date: Aug 27, 2019
Applicant Holder Full Name: KYOWA KIRIN INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NOURIANZ (ISTRADEFYLLINE)
40MG
Marketing Status: Prescription

Active Ingredient: ISTRADEFYLLINE
Proprietary Name: NOURIANZ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022075
Product Number: 002
Approval Date: Aug 27, 2019
Applicant Holder Full Name: KYOWA KIRIN INC
Marketing Status:  Prescription
Patent and Exclusivity Information