osimertinib Oral Tablet

Brand(s)
Tagrisso
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2015-11-13)
Oldest Current Product
2015-11-13
License(s)
NDA
RxNORM
ORAL TABLET\OSIMERTINIB
SPL Active
ORAL\TABLET, FILM COATED\OSIMERTINIB
SPL Moiety
ORAL\TABLET, FILM COATED\OSIMERTINIB

product(s) by strength(s)

osimertinib 40 mg oral tablet

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003101349TagrissoNDAAstrazeneca Pharmaceuticals Lp2015-11-13OSIMERTINIBORALTABLET, FILM COATEDNDA2080655e81b4a7-b971-45e1-9c31-29cea8c87ce7

osimertinib 80 mg oral tablet

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003101350TagrissoNDAAstrazeneca Pharmaceuticals Lp2015-11-13OSIMERTINIBORALTABLET, FILM COATEDNDA2080655e81b4a7-b971-45e1-9c31-29cea8c87ce7

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
15e81b4a7-b971-45e1-9c31-29cea8c87ce7 (view SPL)These highlights do not include all the information needed to use TAGRISSO safely and effectively. See full prescribing information for TAGRISSO. TAGRISSO (osimertinib) tablet, for oral useInitial U.S. Approval: 2015prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2015-11-131003101349, 003101350

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