axitinib Oral Tablet

Brand(s)
Inlyta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2014-08-14)
Oldest Current Product
2012-01-27
License(s)
NDA
RxNORM
ORAL TABLET\AXITINIB
FDAOB
ORAL\TABLET\AXITINIB
SPL Active
ORAL\TABLET, FILM COATED\AXITINIB
SPL Moiety
ORAL\TABLET, FILM COATED\AXITINIB

product(s) by strength(s)

axitinib 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690145InlytaNDAPfizer Labs2012-01-27AXITINIBORALTABLET, FILM COATEDNDA20232484137882-e000-47da-bd5b-fa76ab3c76f9

axitinib 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1635390044InlytaNDAU.S. Pharmaceuticals2012-01-27AXITINIBORALTABLET, FILM COATEDNDA2023248a903e31-936e-4ed7-8a59-59f32374f338

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202324INLYTAPFIZER INC2012-01-27p6534524, SUBSTANCE
p7141581, TREATMENT OF RENAL CELL CARCINOMA
p8791140
NEW CHEMICAL ENTITY [2017-01-27]NDA202324_001, NDA202324_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202324_001RXAXITINIB (1MG)ORALTABLETFalse2012-01-27INLYTA
2NDA202324_002RXAXITINIB (5MG)ORALTABLETTrue2012-01-27INLYTA

patent(s)

#idexpiration dateapplication(s)
1p6534524 (view patent)2020-06-30NDA202324
2p7141581 (view patent)2020-06-30NDA202324
3p8791140 (view patent)2030-08-05NDA202324

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
184137882-e000-47da-bd5b-fa76ab3c76f9 (view SPL)These highlights do not include all the information needed to use INLYTA safely and effectively. See full prescribing information for INLYTA. INLYTA (axitinib) tablets for oral administration Initial U.S. Approval: 2012prescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-08-149000690145, 000690151
28a903e31-936e-4ed7-8a59-59f32374f338 (view SPL)These highlights do not include all the information needed to use INLYTA safely and effectively. See full prescribing information for INLYTA. INLYTA (axitinib) tablets for oral administration Initial U.S. Approval: 2012prescriptionHuman PrescriptionU.S. Pharmaceuticals2015-11-172635390044

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