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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 017837

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 017837

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
08/25/2023	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017837s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017837Orig1s017ltr.pdf
05/21/1996	SUPPL-15	Supplement		Label is not available on this site.
09/30/1985	SUPPL-13	Supplement		Label is not available on this site.
01/22/1985	SUPPL-12	Supplement		Label is not available on this site.
10/04/1983	SUPPL-11	Supplement		Label is not available on this site.
10/25/1983	SUPPL-10	Supplement		Label is not available on this site.
08/17/1981	SUPPL-9	Supplement		Label is not available on this site.
11/16/1978	SUPPL-6	Supplement		Label is not available on this site.
10/14/1977	SUPPL-5	Supplement		Label is not available on this site.
10/14/1977	SUPPL-4	Supplement		Label is not available on this site.
10/14/1977	SUPPL-3	Supplement		Label is not available on this site.
10/14/1977	SUPPL-2	Supplement		Label is not available on this site.
10/14/1977	SUPPL-1	Supplement		Label is not available on this site.

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

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