An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017881s030lbl.pdf
12/01/2023	SUPPL-30	Labeling-Container/Carton Labels	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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017881s010lbl.pdf
06/05/2009	SUPPL-10	Labeling-Container/Carton Labels	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.

Top