Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 017837
Company: ISO TEX

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

Products on BLA 17837

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEGATOPE	ALBUMIN IODINATED I-131 SERUM	0.5mCi/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
MEGATOPE	ALBUMIN IODINATED I-131 SERUM	1mCi/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
MEGATOPE	ALBUMIN IODINATED I-131 SERUM	2mCi/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
MEGATOPE	ALBUMIN IODINATED I-131 SERUM	5uCi/AMP	INJECTABLE;INJECTION	Discontinued	None	No	No
MEGATOPE	ALBUMIN IODINATED I-131 SERUM	20uCi/AMP	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for BLA 017837

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/25/2023	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017837s017lbl.pdf
08/25/2023	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017837s017lbl.pdf