MedPath
FDA Approval

Darzalex Faspro

November 28, 2023

HUMAN PRESCRIPTION DRUG LABEL

Daratumumab(1800 mg in 15 mL)

Manufacturing Establishments (10)

Janssen Biotech, Inc.

Janssen Biotech, Inc.

038978363

Eurofins Lancaster Laboratories, Inc

Janssen Biotech, Inc.

069777290

Bioreliance Corporation

Janssen Biotech, Inc.

147227730

Catalent Indiana, LLC

Janssen Biotech, Inc.

172209277

Janssen Biologics B.V.

Janssen Biotech, Inc.

409612918

Biogen (Denmark) Manufacturing ApS

Janssen Biotech, Inc.

307258082

Cilag AG

Janssen Biotech, Inc.

483237103

Janssen Vaccines Corp.

Janssen Biotech, Inc.

688272061

Janssen Sciences Ireland UC

Janssen Biotech, Inc.

986030167

Charles River Laboratories

Janssen Biotech, Inc.

078495006

Products (1)

Darzalex Faspro

57894-503

BLA761145

BLA (C73585)

SUBCUTANEOUS

November 28, 2023

HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACT
METHIONINEInactive
Code: AE28F7PNPLClass: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
Code: 4Z63YK6E0EClass: ACTIBQuantity: 1800 mg in 15 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 743QUY4VD8Class: ACTIBQuantity: 30000 U in 15 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACT
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