trastuzumab Injectable Solution

Brand(s)
Herceptin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2015-04-29)
Oldest Current Product
1998-09-25
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\TRASTUZUMAB

product(s) by strength(s)

trastuzumab 22 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1502420134HerceptinBLAGenentech, Inc.1998-09-25TRASTUZUMABKIT103792492dbdb2-077e-4064-bff3-372d6af0a7a2

application(s)

#idtitleapprovedtradenamesfda division
1103792trastuzumab Application1998-09-25HerceptinCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1492dbdb2-077e-4064-bff3-372d6af0a7a2 (view SPL)These highlights do not include all the information needed to use Herceptin safely and effectively. See full prescribing information for Herceptin. HERCEPTIN (trastuzumab)Intravenous InfusionInitial U.S. Approval: 1998prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-04-297502420134

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