Application 761145

Type: BLA
Sponsor: JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DARZALEX FASPRO	DARATUMUMAB;HYALURONIDASE-FIHJ	INJECTABLE;INJECTION	120MG;2000UNITS/ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab, hyaluronidase (human recombinant), histidine, histidine monohydrochloride monohydrate, methionine, polysorbate 20, and sorbitol	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current
57894-503	Darzalex Faspro	daratumumab and hyaluronidase-fihj (human recombinant)	Janssen Biotech, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85140	SUPPL	2026-02-24
85045	SUPPL	2026-02-13
84860	SUPPL	2026-01-28
84852	SUPPL	2026-01-28
84256	SUPPL	2025-11-21
84247	SUPPL	2025-11-21
84236	SUPPL	2025-11-20
84187	SUPPL	2025-11-18
84176	SUPPL	2025-11-17
84127	SUPPL	2025-11-07
84124	SUPPL	2025-11-07
79256	SUPPL	2024-07-31
79262	SUPPL	2024-07-30
72560	SUPPL	2022-11-04
72552	SUPPL	2022-11-03
69972	SUPPL	2022-01-26
69963	SUPPL	2022-01-25
69435	SUPPL	2021-12-01
69429	SUPPL	2021-12-01
68054	SUPPL	2021-07-13
68044	SUPPL	2021-07-12
67592	ORIG	2021-05-26
66789	SUPPL	2021-03-16
66782	SUPPL	2021-03-15
66218	SUPPL	2021-02-16
66165	SUPPL	2021-02-09
66029	SUPPL	2021-02-01
65918	SUPPL	2021-01-15
65908	SUPPL	2021-01-14
62823	ORIG	2020-05-05
62799	ORIG	2020-05-01

Application 761145

Related Records#

Application Products#

NDC Listings For This Application#

Documents#