MedPath
FDA Approval

TECENTRIQ

May 19, 2023

HUMAN PRESCRIPTION DRUG LABEL

Atezolizumab(840 mg in 14 mL)

Manufacturing Establishments (5)

F. Hoffmann-La Roche Ltd

Genentech, Inc.

485244961

Roche Diagnostics GmbH

Genentech, Inc.

323105205

Genentech, Inc.

Genentech, Inc.

080129000

F. Hoffmann-La Roche AG

Genentech, Inc.

482242971

Roche Singapore Technical Operation, Pte. Ltd. (RSTO)

Genentech, Inc.

937189173

Products (2)

TECENTRIQ

50242-918

BLA761034

BLA (C73585)

INTRAVENOUS

April 30, 2023

Code: 52CMI0WC3YClass: ACTIBQuantity: 840 mg in 14 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 43.4 mg in 14 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 11.5 mg in 14 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 575.1 mg in 14 mL
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 5.6 mg in 14 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

TECENTRIQ

50242-917

BLA761034

BLA (C73585)

INTRAVENOUS

April 30, 2023

Code: 52CMI0WC3YClass: ACTIBQuantity: 1200 mg in 20 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 62 mg in 20 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 16.5 mg in 20 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 821.6 mg in 20 mL
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 8 mg in 20 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
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