Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016515
Company: CURIUM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM IODIDE I 131 SODIUM IODIDE I-131 3.5-150mCi/VIAL SOLUTION;ORAL Discontinued None Yes No
SODIUM IODIDE I 131 SODIUM IODIDE I-131 0.8-100mCi CAPSULE;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
08/18/1971 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
02/06/2018 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016515s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016515Orig1s016ltr.pdf
10/20/2015 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016515s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016515Orig1s013ltr.pdf
03/20/2014 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016515s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016515Orig1s012ltr.pdf
02/03/2012 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016515s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016515s010ltr.pdf
07/11/1983 SUPPL-7 Labeling

Label is not available on this site.

06/07/1988 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/27/1977 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/27/1977 SUPPL-3 Labeling

Label is not available on this site.

10/27/1977 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1976 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2018 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016515s016lbl.pdf
10/20/2015 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016515s013lbl.pdf
03/20/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016515s012lbl.pdf
02/03/2012 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016515s010lbl.pdf

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