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Last Updated: May 23, 2024

Details for New Drug Application (NDA): 203469


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NDA 203469 describes ICLUSIG, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ICLUSIG profile page.

The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.
Summary for 203469
Tradename:ICLUSIG
Applicant:Takeda Pharms Usa
Ingredient:ponatinib hydrochloride
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 203469
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 203469
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469 NDA Takeda Pharmaceuticals America, Inc. 63020-533 63020-533-30 30 TABLET, FILM COATED in 1 BOTTLE (63020-533-30)
ICLUSIG ponatinib hydrochloride TABLET;ORAL 203469 NDA Takeda Pharmaceuticals America, Inc. 63020-534 63020-534-30 30 TABLET, FILM COATED in 1 BOTTLE (63020-534-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Dec 14, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 19, 2027
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ ALL) IN COMBINATION WITH CHEMOTHERAPY
Patent:⤷  Sign UpPatent Expiration:Dec 12, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
Patent:⤷  Sign UpPatent Expiration:Dec 12, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN

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