An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761145
Company: JANSSEN BIOTECH

Products on BLA 761145

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DARZALEX FASPRO	DARATUMUMAB;HYALURONIDASE-FIHJ	120MG;2000UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761145

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2020	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761145Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761145Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2022	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761145s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761145Orig1s018ltr.pdf
01/21/2022	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761145s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761145Orig1s012ltr.pdf
11/30/2021	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761145Orig1s009ltr.pdf
02/08/2021	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761145Orig1s008ltr.pdf
07/09/2021	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761145Orig1s007ltr.pdf
03/12/2021	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761145Orig1s005ltr.pdf
01/15/2021	SUPPL-2	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s002lbl.pdf
01/11/2021	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761145Orig1s001ltr.pdf

Labels for BLA 761145

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2022	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761145s018lbl.pdf
01/21/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761145s012lbl.pdf
11/30/2021	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s009lbl.pdf
07/09/2021	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s007lbl.pdf
03/12/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s005lbl.pdf
02/08/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s008lbl.pdf
01/15/2021	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s002lbl.pdf
01/11/2021	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s001lbl.pdf
05/01/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf

Top