Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017630
Company: GE HEALTHCARE
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SODIUM IODIDE I 123 SODIUM IODIDE I-123 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SOLUTION;ORAL Discontinued None No No
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.

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