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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 219293

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DANZITEN (NILOTINIB TARTRATE)
EQ 71MG BASE
Marketing Status: Prescription
Active Ingredient: NILOTINIB TARTRATE
Proprietary Name: DANZITEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 71MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N219293
Product Number: 001
Approval Date: Nov 7, 2024
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DANZITEN (NILOTINIB TARTRATE)
EQ 95MG BASE
Marketing Status: Prescription
Active Ingredient: NILOTINIB TARTRATE
Proprietary Name: DANZITEN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 95MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N219293
Product Number: 002
Approval Date: Nov 7, 2024
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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