ponatinib Oral Tablet

Brand(s)
Iclusig
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ariad Pharmaceuticals, Inc. (2014-10-07)
Oldest Current Product
2012-12-14
License(s)
NDA
RxNORM
ORAL TABLET\PONATINIB
FDAOB
ORAL\TABLET\PONATINIB HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\PONATINIB HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\PONATINIB

product(s) by strength(s)

ponatinib 15 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1761890535IclusigNDAAriad Pharmaceuticals, Inc.2012-12-14PONATINIB HYDROCHLORIDEORALTABLET, FILM COATEDNDA203469807f988e-117b-4497-934d-73aa78baac71

ponatinib 45 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1761890534IclusigNDAAriad Pharmaceuticals, Inc.2012-12-14PONATINIB HYDROCHLORIDEORALTABLET, FILM COATEDNDA203469807f988e-117b-4497-934d-73aa78baac71

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203469ICLUSIGARIAD PHARMACEUTICALS INC2012-12-14p9029533, A METHOD FOR THE TREATMENT OF LEUKEMIAS/ A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA/ A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN/ A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA/ A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA
p8114874, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2019-12-14]
NEW CHEMICAL ENTITY [2017-12-14]
NDA203469_001, NDA203469_002, NDA203469_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203469_001RXPONATINIB HYDROCHLORIDE (EQ 15MG BASE)ORALTABLETFalse2012-12-14ICLUSIG
2NDA203469_002RXPONATINIB HYDROCHLORIDE (EQ 45MG BASE)ORALTABLETTrue2012-12-14ICLUSIG
3NDA203469_003RXPONATINIB HYDROCHLORIDE (EQ 30MG BASE)ORALTABLETFalse2015-04-23ICLUSIG

patent(s)

#idexpiration dateapplication(s)
1p8114874 (view patent)2026-12-22NDA203469
2p9029533 (view patent)2026-12-22NDA203469

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1807f988e-117b-4497-934d-73aa78baac71 (view SPL)These highlights do not include all the information needed to use ICLUSIG safely and effectively. See full prescribing information for ICLUSIG. ICLUSIG (ponatinib) tablets for oral use Initial U.S. Approval: 2012prescriptionHuman PrescriptionAriad Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-10-077761890534, 761890535

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII