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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 017836
Company: ISO TEX

This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 017836

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JEANATOPE	ALBUMIN IODINATED I-125 SERUM	500uCi/0.5ML	INJECTABLE;INJECTION	Prescription	None	No	No
JEANATOPE	ALBUMIN IODINATED I-125 SERUM	1,000uCi/ML	INJECTABLE;INJECTION	Prescription	None	No	No
JEANATOPE	ALBUMIN IODINATED I-125 SERUM	100uCi/10ML (10uCi/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 017836

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/1976	ORIG-1	Approval		N/A		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/12/2023	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017836s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017836Orig1s009ltr.pdf
06/08/2004	SUPPL-8	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17836scs008ltr.pdf
05/21/1996	SUPPL-7	Supplement		Label is not available on this site.
02/03/1977	SUPPL-4	Supplement		Label is not available on this site.
02/03/1977	SUPPL-3	Supplement		Label is not available on this site.
02/03/1977	SUPPL-2	Supplement		Label is not available on this site.
10/08/1976	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 017836

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/12/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017836s009lbl.pdf

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