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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761404
Company: CELLTRION INC

Products on BLA 761404

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OSENVELT	DENOSUMAB-BMWO	120MG/1.7ML(70MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No
STOBOCLO	DENOSUMAB-BMWO	60MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761404

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/2025/761404s000lbl.pdf#page=33 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761404Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761404Orig2s000TOC.html
02/28/2025	ORIG-1	Approval		N/A	Label (PDF) Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761404s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761404s000Orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761404Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761404Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/10/2025	SUPPL-3	Supplement	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761404s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761404Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761404Orig1s003ltr.pdf

Labels for BLA 761404

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/2025/761404s000lbl.pdf#page=33
09/10/2025	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761404s003lbl.pdf
02/28/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761404s000lbledt.pdf
02/28/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761404s000Orig2lbl.pdf

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