ceritinib Oral Capsule

Brand(s)
Zykadia
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2014-07-22)
Oldest Current Product
2014-04-29
License(s)
NDA
RxNORM
ORAL CAPSULE\CERITINIB
FDAOB
ORAL\CAPSULE\CERITINIB
SPL Active
ORAL\CAPSULE\CERITINIB
SPL Moiety
ORAL\CAPSULE\CERITINIB

product(s) by strength(s)

ceritinib 150 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780640ZykadiaNDANovartis Pharmaceuticals Corporation2014-04-29CERITINIBORALCAPSULENDA205755fff5d805-4ffd-4e8e-8e63-6f129697563e

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205755ZYKADIANOVARTIS PHARMACEUTICALS CORP2014-04-29p8377921, TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
p7964592, SUBSTANCE
p8703787, TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
p8039474, SUBSTANCE
p7893074, SUBSTANCE
p8039479, SUBSTANCE
p7153964, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2021-04-29]
NEW CHEMICAL ENTITY [2019-04-29]
NDA205755_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205755_001RXCERITINIB (150MG)ORALCAPSULETrue2014-04-29ZYKADIA

patent(s)

#idexpiration dateapplication(s)
1p7153964 (view patent)2021-02-26NDA205755
2p7893074 (view patent)2026-04-25NDA205755
3p7964592 (view patent)2027-01-13NDA205755
4p8039474 (view patent)2030-06-29NDA205755
5p8039479 (view patent)2030-06-29NDA205755
6p8377921 (view patent)2027-11-20NDA205755
7p8703787 (view patent)2032-02-02NDA205755

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1fff5d805-4ffd-4e8e-8e63-6f129697563e (view SPL)These highlights do not include all the information needed to use ZYKADIA safely and effectively. See full prescribing information for ZYKADIA. ZYKADIATM (ceritinib) capsules, for oral use Initial U.S. Approval: 2014prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2014-07-222000780640

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