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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761116
Company: STEMLINE THERAPEUTICS INC

Products on BLA 761116

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELZONRIS	TAGRAXOFUSP-ERZS	1000MCG	SOLUTION;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761116

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2018	ORIG-1	Approval		N/A; Orphan	Label (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761116s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761116Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2023	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761116s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761116Orig1s009ltr.pdf
11/03/2022	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761116s007lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761116Orig1s007ltr.pdf
10/27/2022	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761116s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761116Orig1s005ltr.pdf

Labels for BLA 761116

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/26/2023	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761116s009lbl.pdf
07/26/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761116s009lbl.pdf
11/03/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761116s007lbledt.pdf
10/27/2022	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761116s005lbl.pdf
12/21/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761116s000lbl.pdf

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