Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017630
Company: GE HEALTHCARE

Products on NDA 017630

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM IODIDE I 123	SODIUM IODIDE I-123	100uCi	CAPSULE;ORAL	Discontinued	None	No	No
SODIUM IODIDE I 123	SODIUM IODIDE I-123	2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SOLUTION;ORAL	Discontinued	None	No	No
SODIUM IODIDE I 123	SODIUM IODIDE I-123	200uCi	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017630

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/1976	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
06/15/2005	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017630s013ltr.pdf
02/28/1997	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/10/1997	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/08/1993	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
11/18/1988	SUPPL-8	Labeling		Label is not available on this site.
10/01/1982	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/01/1986	SUPPL-6	Labeling		Label is not available on this site.
05/06/1980	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
03/22/1982	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
07/11/1979	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/03/1977	SUPPL-2	Labeling		Label is not available on this site.