Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203640

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NILOTINIB HYDROCHLORIDE (NILOTINIB HYDROCHLORIDE)
EQ 50MG BASE
Marketing Status: Discontinued

Active Ingredient: NILOTINIB HYDROCHLORIDE
Proprietary Name: NILOTINIB HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203640
Product Number: 001
Approval Date: Jan 5, 2024
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NILOTINIB HYDROCHLORIDE (NILOTINIB HYDROCHLORIDE)
EQ 150MG BASE
Marketing Status: Discontinued

Active Ingredient: NILOTINIB HYDROCHLORIDE
Proprietary Name: NILOTINIB HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203640
Product Number: 002
Approval Date: Jan 5, 2024
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

NILOTINIB HYDROCHLORIDE (NILOTINIB HYDROCHLORIDE)
EQ 200MG BASE
Marketing Status: Discontinued

Active Ingredient: NILOTINIB HYDROCHLORIDE
Proprietary Name: NILOTINIB HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203640
Product Number: 003
Approval Date: Jan 5, 2024
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Discontinued
Patent and Exclusivity Information