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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203469

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ICLUSIG (PONATINIB HYDROCHLORIDE)
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: PONATINIB HYDROCHLORIDE
Proprietary Name: ICLUSIG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203469
Product Number: 004
Approval Date: Dec 18, 2020
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ICLUSIG (PONATINIB HYDROCHLORIDE)
EQ 15MG BASE
Marketing Status: Prescription
Active Ingredient: PONATINIB HYDROCHLORIDE
Proprietary Name: ICLUSIG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203469
Product Number: 001
Approval Date: Dec 14, 2012
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ICLUSIG (PONATINIB HYDROCHLORIDE)
EQ 30MG BASE
Marketing Status: Prescription
Active Ingredient: PONATINIB HYDROCHLORIDE
Proprietary Name: ICLUSIG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203469
Product Number: 003
Approval Date: Apr 23, 2015
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ICLUSIG (PONATINIB HYDROCHLORIDE)
EQ 45MG BASE
Marketing Status: Prescription
Active Ingredient: PONATINIB HYDROCHLORIDE
Proprietary Name: ICLUSIG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 45MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203469
Product Number: 002
Approval Date: Dec 14, 2012
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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