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Details for New Drug Application (NDA): 203469

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

The generic ingredient in ICLUSIG is ponatinib hydrochloride. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.

Summary for NDA: 203469

Tradename:
ICLUSIG
Applicant:
Ariad
Ingredient:
ponatinib hydrochloride
Patents:2
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 ARIAD Pharmaceuticals, Inc. 76189-533 76189-533-30 30 TABLET, FILM COATED in 1 BOTTLE (76189-533-30)
ICLUSIG
ponatinib hydrochloride
TABLET;ORAL 203469 NDA ARIAD Pharmaceuticals, Inc. 76189-534 76189-534-30 30 TABLET, FILM COATED in 1 BOTTLE (76189-534-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 15MG BASE
Approval Date:Dec 14, 2012TE:RLD:No
Patent:8,114,874Patent Expiration:Dec 22, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:9,029,533Patent Expiration:Dec 22, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR THE TREATMENT OF LEUKEMIAS
Patent:9,029,533Patent Expiration:Dec 22, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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