crizotinib Oral Capsule

Brand(s)
Xalkori
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2015-09-24)
Oldest Current Product
2011-08-26
License(s)
NDA
RxNORM
ORAL CAPSULE\CRIZOTINIB
FDAOB
ORAL\CAPSULE\CRIZOTINIB
SPL Active
ORAL\CAPSULE\CRIZOTINIB
SPL Moiety
ORAL\CAPSULE\CRIZOTINIB

product(s) by strength(s)

crizotinib 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000698141XalkoriNDAPfizer Labs2011-08-26CRIZOTINIBORALCAPSULENDA2025702a51b0de-47d6-455e-a94c-d2c737b04ff7

crizotinib 250 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000698140XalkoriNDAPfizer Labs2011-08-26CRIZOTINIBORALCAPSULENDA2025702a51b0de-47d6-455e-a94c-d2c737b04ff7

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202570XALKORIPF PRISM CV2011-08-26p8785632
p7230098
p7825137, TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
p8217057, SUBSTANCE
p7858643, SUBSTANCE
INFORMATION ADDED TO THE LABELING REGARDING PREVIOUSLY UNTREATED ALK-POSITIVE METASTATIC NON SMALL CELL LUNG CANCER (NSCLC) [2018-09-14]
ORPHAN DRUG EXCLUSIVITY [2018-08-26]
NEW CHEMICAL ENTITY [2016-08-26]
NDA202570_001, NDA202570_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202570_001RXCRIZOTINIB (200MG)ORALCAPSULEFalse2011-08-26XALKORI
2NDA202570_002RXCRIZOTINIB (250MG)ORALCAPSULETrue2011-08-26XALKORI

patent(s)

#idexpiration dateapplication(s)
1p7230098 (view patent)2025-08-26NDA202570
2p7825137 (view patent)2027-05-12NDA202570
3p7858643 (view patent)2029-10-08NDA202570
4p8217057 (view patent)2029-11-06NDA202570
5p8785632 (view patent)2025-03-01NDA202570

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12a51b0de-47d6-455e-a94c-d2c737b04ff7 (view SPL)These highlights do not include all the information needed to use XALKORI safely and effectively. See full prescribing information for XALKORI. XALKORI (crizotinib) capsules, for oral use Initial U.S. Approval: 2011prescriptionHuman PrescriptionPfizer LabsAPI MANUFACTURE, REPACK2015-09-2421000698140, 000698141

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