Manufacturing Establishments (6)
Genentech, Inc.
Genentech, Inc.
080129000
Roche Diagnostics GmbH
Genentech, Inc.
315028860
Genentech, Inc
Genentech, Inc.
146373191
F. Hoffmann-La Roche Ltd
Genentech, Inc.
485244961
F. Hoffmann-La Roche AG
Genentech, Inc.
482242971
Roche Singapore Technical Operations Pte. Ltd. (RSTO)
Genentech, Inc.
937189173
Products (2)
Rituxan Hycela
50242-109
BLA761064
BLA (C73585)
SUBCUTANEOUS
November 16, 2022
HISTIDINEInactive
Code: 4QD397987EClass: IACT
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACT
METHIONINEInactive
Code: AE28F7PNPLClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
RituximabActive
Code: 4F4X42SYQ6Class: ACTIBQuantity: 120 mg in 1 mL
Code: 743QUY4VD8Class: ACTIBQuantity: 2000 U in 1 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACT
Rituxan Hycela
50242-108
BLA761064
BLA (C73585)
SUBCUTANEOUS
November 16, 2022
RituximabActive
Code: 4F4X42SYQ6Class: ACTIBQuantity: 120 mg in 1 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACT
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACT
METHIONINEInactive
Code: AE28F7PNPLClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 743QUY4VD8Class: ACTIBQuantity: 2000 U in 1 mL