Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207968

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JADENU SPRINKLE (DEFERASIROX)
90MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: JADENU SPRINKLE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 90MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N207968
Product Number: 001
Approval Date: May 18, 2017
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

JADENU SPRINKLE (DEFERASIROX)
180MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: JADENU SPRINKLE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 180MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N207968
Product Number: 002
Approval Date: May 18, 2017
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

JADENU SPRINKLE (DEFERASIROX)
360MG
Marketing Status: Prescription

Active Ingredient: DEFERASIROX
Proprietary Name: JADENU SPRINKLE
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 360MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N207968
Product Number: 003
Approval Date: May 18, 2017
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information