Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022068

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TASIGNA (NILOTINIB HYDROCHLORIDE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: NILOTINIB HYDROCHLORIDE
Proprietary Name: TASIGNA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022068
Product Number: 003
Approval Date: Mar 22, 2018
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

TASIGNA (NILOTINIB HYDROCHLORIDE)
EQ 150MG BASE
Marketing Status: Prescription

Active Ingredient: NILOTINIB HYDROCHLORIDE
Proprietary Name: TASIGNA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022068
Product Number: 002
Approval Date: Jun 17, 2010
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

TASIGNA (NILOTINIB HYDROCHLORIDE)
EQ 200MG BASE
Marketing Status: Prescription

Active Ingredient: NILOTINIB HYDROCHLORIDE
Proprietary Name: TASIGNA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022068
Product Number: 001
Approval Date: Oct 29, 2007
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information