Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017693
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNETIUM TC 99M GENERATOR TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 830-16600mCi/GENERATOR SOLUTION;INTRAVENOUS, ORAL Discontinued None No No
TECHNETIUM TC 99M GENERATOR TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR 68-2703mCi/GENERATOR SOLUTION;INTRAVENOUS, ORAL Discontinued None Yes 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
11/15/1976 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
08/07/2015 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017693s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017693Orig1s029ltr.pdf
01/05/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/14/2014 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017693s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017693Orig1s026ltr.pdf
12/13/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/28/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/24/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/11/1993 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/27/1995 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/17/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/16/1990 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

06/30/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/31/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/08/1987 SUPPL-13 Labeling

Label is not available on this site.

06/01/1988 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1984 SUPPL-10 Labeling

Label is not available on this site.

02/09/1983 SUPPL-9 Efficacy

Label is not available on this site.

06/07/1982 SUPPL-8 Labeling

Label is not available on this site.

12/28/1979 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/20/1978 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/31/1979 SUPPL-5 Labeling

Label is not available on this site.

02/13/1978 SUPPL-3 Labeling

Label is not available on this site.

01/19/1978 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/19/1978 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/07/2015 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017693s029lbl.pdf
10/14/2014 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017693s026lbl.pdf

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