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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 017881
Company: DRAXIMAGE

Products on BLA 017881

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT	TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT	N/A	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 017881

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1987	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
12/01/2023	SUPPL-30	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017881s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017881Orig1s030ltr.pdf
10/20/2017	SUPPL-26	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017881s026lbl.pdf
06/09/2016	SUPPL-25	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017881Orig1s025ltr.pdf
03/01/2016	SUPPL-24	Supplement		Label is not available on this site.
05/11/2015	SUPPL-23	Supplement		Label is not available on this site.
03/04/2013	SUPPL-22	Supplement		Label is not available on this site.
09/23/2011	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017881s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017881s016ltr.pdf
06/05/2009	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017881s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017881s010ltr.pdf
10/17/2008	SUPPL-9	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017881s009ltr.pdf
07/23/2002	SUPPL-4	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17881scm004ltr.pdf
04/02/1999	SUPPL-3	Supplement		Label is not available on this site.
04/02/1999	SUPPL-2	Supplement		Label is not available on this site.
07/17/1989	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 017881

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/01/2023	SUPPL-30	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017881s030lbl.pdf
12/01/2023	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017881s030lbl.pdf
10/20/2017	SUPPL-26	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017881s026lbl.pdf
09/23/2011	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017881s016lbl.pdf
06/05/2009	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017881s010lbl.pdf
06/05/2009	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017881s010lbl.pdf

Therapeutic Equivalents for BLA 017881

TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT

There are no Therapeutic Equivalents.

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