Biologic License Application (BLA): 761344
Company: AMGEN INC

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMDELLTRA	TARLATAMAB-DLLE	1MG	INJECTABLE;INJECTION	Prescription	None	No	No
IMDELLTRA	TARLATAMAB-DLLE	10MG	INJECTABLE;INJECTION	Prescription	None	No	No

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/16/2024	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761344Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761344Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/763144Orig1s001.pdf

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/11/2026	SUPPL-2	Supplement		Label is not available on this site.
11/19/2025	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761344s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761344Orig1s001ltr.pdf

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/19/2025	SUPPL-1	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761344s001lbl.pdf
05/16/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf