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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 217379

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CAVHANZA (NILOTINIB)
60MG
Marketing Status: Prescription
Active Ingredient: NILOTINIB
Proprietary Name: CAVHANZA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N217379
Product Number: 001
Approval Date: May 29, 2026
Applicant Holder Full Name: FLEX PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
CAVHANZA (NILOTINIB)
80MG
Marketing Status: Prescription
Active Ingredient: NILOTINIB
Proprietary Name: CAVHANZA
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217379
Product Number: 002
Approval Date: May 29, 2026
Applicant Holder Full Name: FLEX PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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