MedPath
FDA Approval

Inmazeb

December 20, 2022

HUMAN PRESCRIPTION DRUG LABEL

Atoltivimab(483.3 mg in 14.5 mL)
Maftivimab(483.3 mg in 14.5 mL)
Odesivimab(483.3 mg in 14.5 mL)

Manufacturing Establishments (2)

Regeneron Pharmaceuticals, Inc.

Regeneron Pharmaceuticals, Inc.

945589711

Regeneron Ireland Designated Activity Company

Regeneron Pharmaceuticals, Inc.

986063166

Products (2)

Inmazeb

61755-019

BLA761169

BLA (C73585)

INTRAVENOUS

May 19, 2022

Code: FJZ07Q63VYClass: ACTIBQuantity: 483.3 mg in 14.5 mL
Code: KOP95331M4Class: ACTIBQuantity: 483.3 mg in 14.5 mL
Code: UY9LQ8P6HWClass: ACTIBQuantity: 483.3 mg in 14.5 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
SucroseInactive
Code: C151H8M554Class: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT

Inmazeb

61755-018

BLA761169

BLA (C73585)

INTRAVENOUS

May 19, 2022

Code: FJZ07Q63VYClass: ACTIBQuantity: 241.7 mg in 14.5 mL
Code: KOP95331M4Class: ACTIBQuantity: 241.7 mg in 14.5 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACT
Code: UY9LQ8P6HWClass: ACTIBQuantity: 241.7 mg in 14.5 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
SucroseInactive
Code: C151H8M554Class: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
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