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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019829
Company: GE HEALTHCARE

Products on NDA 019829

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019829

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-Package Insert, Labeling-Container/Carton Labels	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.

Labels for NDA 019829

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