Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017944
Company: GE HEALTHCARE

Products on NDA 017944

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MPI DMSA KIDNEY REAGENT	TECHNETIUM TC-99M SUCCIMER KIT	N/A **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017944

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/1982	ORIG-1	Approval	Type 1 - New Molecular Entity	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
02/28/2014	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
11/22/2013	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
11/24/2003	SUPPL-18	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17944slr018ltr.pdf
11/25/2002	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
04/10/2001	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/29/2000	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/12/1999	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
11/16/1995	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
07/15/1993	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/17/1994	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
11/15/1989	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/17/1989	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
02/17/1989	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/12/1985	SUPPL-5	Labeling		Label is not available on this site.
01/30/1985	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
01/23/1986	SUPPL-3	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
05/27/1983	SUPPL-2	Labeling		Label is not available on this site.
04/10/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.