Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017881
Company: DRAXIMAGE
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 BS Yes Yes
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 Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/20/2017 SUPPL-26 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017881s026lbl.pdf
06/09/2016 SUPPL-25 Manufacturing (CMC) 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 Manufacturing (CMC)

Label is not available on this site.

05/11/2015 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/04/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/23/2011 SUPPL-16 Labeling-Container/Carton Labels 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 Labeling-Package Insert, Labeling-Container/Carton Labels 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 Labeling 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 Manufacturing (CMC) 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 Labeling

Label is not available on this site.

04/02/1999 SUPPL-2 Labeling

Label is not available on this site.

07/17/1989 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT

There are no Therapeutic Equivalents.

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