Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017264
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNETIUM TC-99M PENTETATE KIT TECHNETIUM TC-99M PENTETATE 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
02/14/1974 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
02/17/1989 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/23/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/27/1982 SUPPL-21 Labeling

Label is not available on this site.

10/08/1982 SUPPL-20 Labeling

Label is not available on this site.

08/15/1980 SUPPL-18 Labeling

Label is not available on this site.

09/13/1979 SUPPL-14 Labeling

Label is not available on this site.

09/13/1979 SUPPL-13 Labeling

Label is not available on this site.

09/13/1979 SUPPL-12 Labeling

Label is not available on this site.

09/13/1979 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/13/1979 SUPPL-9 Labeling

Label is not available on this site.

04/26/1977 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1976 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1976 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1975 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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