Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761398
Company: FRESENIUS KABI USA LLC

Products on BLA 761398

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BOMYNTRA	DENOSUMAB-BNHT	120MG/1.7ML (70 MG/ML)	INJECTION	Prescription	None	No	No
CONEXXENCE	DENOSUMAB-BNHT	60MG/ML	INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761398

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2025	ORIG-2	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761398Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761398Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761398Orig1Orig2s000TOC.html
03/25/2025	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761398Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761398Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761398Orig1Orig2s000TOC.html

Labels for BLA 761398

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2025	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761398Orig2s000lbl.pdf
03/25/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761398Orig1s000lbl.pdf