Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017264
Company: GE HEALTHCARE

Products on NDA 017264

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017264

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.