# DARZALEX FASPRO
> **BLA761145** · Biologics License Application · Sponsor: JANSSEN BIOTECH · Approved 2020-05-01
## Drug
- **FDA Application Number:** BLA761145
- **Application type:** Biologics License Application
- **Brand name:** DARZALEX FASPRO
- **Generic name:** DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT)
- **Active ingredients:** DARATUMUMAB AND HYALURONIDASE-FIHJ
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** JANSSEN BIOTECH
- **Manufacturer:** Janssen Biotech, Inc.
- **First approval:** 2020-05-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761145)
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