Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016923
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESULOID TECHNETIUM TC-99M SULFUR COLLOID KIT N/A SOLUTION;INJECTION, ORAL 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
06/10/1974 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
01/25/1991 SUPPL-20 Efficacy-New Indication

Label is not available on this site.

03/13/2009 SUPPL-19 Labeling

Label is not available on this site.

05/18/1988 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/23/1985 SUPPL-17 Efficacy

Label is not available on this site.

09/30/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/19/1983 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2009 SUPPL-14 Labeling

Label is not available on this site.

07/20/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1982 SUPPL-12 Labeling

Label is not available on this site.

08/02/1983 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/25/1980 SUPPL-10 Labeling

Label is not available on this site.

04/30/1979 SUPPL-9 Labeling

Label is not available on this site.

03/13/2009 SUPPL-8 Labeling

Label is not available on this site.

03/20/1978 SUPPL-7 Labeling

Label is not available on this site.

01/31/1977 SUPPL-6 Labeling

Label is not available on this site.

01/31/1977 SUPPL-5 Labeling

Label is not available on this site.

07/15/1976 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/10/1976 SUPPL-2 Labeling

Label is not available on this site.

08/22/1975 SUPPL-1 Labeling

Label is not available on this site.

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