Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 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 None No No
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
10/20/2017 SUPPL-26 Supplement

Label is not available on this site.

06/09/2016 SUPPL-25 Supplement

Label is not available on this site.

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 is not available on this site.

06/05/2009 SUPPL-10 Supplement

Label is not available on this site.

10/17/2008 SUPPL-9 Supplement

Label is not available on this site.

07/23/2002 SUPPL-4 Supplement

Label is not available on this site.

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.

TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT

There are no Therapeutic Equivalents.

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