Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019829
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CERETEC TECHNETIUM TC-99M EXAMETAZIME KIT N/A INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/30/1988 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/19/2018 SUPPL-34 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019829s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019829Orig1s034ltr.pdf
04/08/2016 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/27/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/05/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019829s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019829Orig1s026ltr.pdf
03/08/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/15/2005 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019829s019ltr.pdf
11/25/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/2001 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/10/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/29/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/12/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1996 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/25/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1995 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/07/1995 SUPPL-5 Efficacy-New Indication

Label is not available on this site.

04/07/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/19/2018 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019829s034lbl.pdf
09/19/2018 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019829s034lbl.pdf
08/05/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019829s026lbl.pdf

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