tofacitinib Oral Tablet

Brand(s)
Xeljanz
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Labs (2015-06-12)
Oldest Current Product
2012-11-09
License(s)
NDA
RxNORM
ORAL TABLET\TOFACITINIB
FDAOB
ORAL\TABLET\TOFACITINIB CITRATE
SPL Active
ORAL\TABLET, FILM COATED\TOFACITINIB CITRATE
SPL Moiety
ORAL\TABLET, FILM COATED\TOFACITINIB

product(s) by strength(s)

tofacitinib 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000691001XeljanzNDAPfizer Labs2012-11-09TOFACITINIB CITRATEORALTABLET, FILM COATEDNDA203214cf74ba2f-afc5-4baa-8594-979c889a5831

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203214XELJANZPF PRISM CV2012-11-06p7265221
pRE41783
p6965027
p6956041, SUBSTANCE
p7301023
p7091208, TREATMENT OF RHEUMATOID ARTHRITIS
NEW CHEMICAL ENTITY [2017-11-06]
ADDITION OF INFORMATION TO THE CLINICAL STUDIES - RADIOGRAPHIC RESPONSE SECTION OF THE PACKAGE INSERT [2017-02-21]
NDA203214_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203214_001RXTOFACITINIB CITRATE (EQ 5MG BASE)ORALTABLETTrue2012-11-06XELJANZ

patent(s)

#idexpiration dateapplication(s)
1p6956041 (view patent)2020-12-08NDA203214
2p6965027 (view patent)2023-03-25NDA203214
3p7091208 (view patent)2020-12-08NDA203214
4p7265221 (view patent)2020-12-08NDA203214
5p7301023 (view patent)2022-05-23NDA203214
6pRE41783 (view patent)2020-12-08NDA203214

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
168e3d6b2-7838-4d2d-a417-09d919b43e13 (view SPL)These highlights do not include all the information needed to use XELJANZ safely and effectively. See full prescribing information for XELJANZ. XELJANZ (tofacitinib) tablets for oral administrationInitial U.S. Approval: 2012prescriptionHuman PrescriptionU.S. PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2012-11-071635390012
2cf74ba2f-afc5-4baa-8594-979c889a5831 (view SPL)These highlights do not include all the information needed to use XELJANZ safely and effectively. See full prescribing information for XELJANZ. XELJANZ (tofacitinib) tablets, for oral useInitial U.S. Approval: 2012prescriptionHuman PrescriptionPfizer LabsANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-06-1212000691001

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