Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 017833
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MACROTEC TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT N/A INJECTABLE;INJECTION Discontinued 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
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
05/01/2001 SUPPL-12 Supplement

Label is not available on this site.

03/21/1994 SUPPL-11 Supplement

Label is not available on this site.

10/06/1989 SUPPL-10 Supplement

Label is not available on this site.

09/30/1985 SUPPL-8 Supplement

Label is not available on this site.

07/06/1984 SUPPL-7 Supplement

Label is not available on this site.

06/12/1978 SUPPL-4 Supplement

Label is not available on this site.

07/13/1977 SUPPL-3 Supplement

Label is not available on this site.

04/25/1977 SUPPL-2 Supplement

Label is not available on this site.

07/13/1977 SUPPL-1 Supplement

Label is not available on this site.

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