Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125509
Company: ELUSYS THERAPEUTICS INC

• Summary Review

Products on BLA 125509

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANTHIM	OBILTOXAXIMAB	600MG/6ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125509

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2016	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125509lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125509Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125509Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125509Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2019	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125509s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125509Orig1s015ltr.pdf
10/20/2016	SUPPL-1	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125509s001lbl.pdf

Labels for BLA 125509

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125509s015lbl.pdf
10/20/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125509s001lbl.pdf
03/18/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125509lbl.pdf