Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017784
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNETIUM TC 99M TSC 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
11/18/1976 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
12/15/1988 SUPPL-19 Labeling

Label is not available on this site.

02/17/1989 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/23/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/02/1987 SUPPL-15 Efficacy-New Patient Population

Label is not available on this site.

04/19/1985 SUPPL-14 Labeling

Label is not available on this site.

12/07/1982 SUPPL-13 Labeling

Label is not available on this site.

12/07/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/27/1981 SUPPL-11 Labeling

Label is not available on this site.

08/12/1982 SUPPL-10 Labeling

Label is not available on this site.

08/28/1978 SUPPL-7 Labeling

Label is not available on this site.

10/09/1979 SUPPL-6 Labeling

Label is not available on this site.

09/12/1977 SUPPL-4 Labeling

Label is not available on this site.

09/13/1977 SUPPL-3 Labeling

Label is not available on this site.

08/09/1977 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1977 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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