ado-trastuzumab emtansine Injection

Brand(s)
KADCYLA
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-05-31)
Oldest Current Product
2013-02-22
License(s)
BLA
RxNORM
INJECTION\ADO-TRASTUZUMAB EMTANSINE
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ADO-TRASTUZUMAB EMTANSINE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ADO-TRASTUZUMAB EMTANSINE

product(s) by strength(s)

ado-trastuzumab emtansine 100 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420088KADCYLABLAGenentech, Inc.2013-02-22ADO-TRASTUZUMAB EMTANSINEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION12542723f3c1f4-0fc8-4804-a9e3-04cf25dd302e

ado-trastuzumab emtansine 160 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502420087KADCYLABLAGenentech, Inc.2013-02-22ADO-TRASTUZUMAB EMTANSINEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION12542723f3c1f4-0fc8-4804-a9e3-04cf25dd302e

application(s)

#idtitleapprovedtradenamesfda division
1125427ado-trastuzumab emtansine Application2013-02-22KadcylaCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
123f3c1f4-0fc8-4804-a9e3-04cf25dd302e (view SPL)These highlights do not include all the information needed to use KADCYLA safely and effectively. See full prescribing information for KADCYLA. KADCYLA (ado-trastuzumab emtansine) for injection, for intravenous use Initial U.S. Approval: 2013prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, LABEL, PACK2015-05-315502420087, 502420088

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