Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021305
Company: JUBILANT DRAXIMAGE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HICON SODIUM IODIDE I-131 1-250mCi/0.25ML SOLUTION;ORAL Discontinued None No No
HICON SODIUM IODIDE I-131 1-500mCi/0.5ML SOLUTION;ORAL Discontinued None No No
HICON SODIUM IODIDE I-131 1-1000mCi/ML SOLUTION;ORAL Discontinued None No No
HICON SODIUM IODIDE I-131 250-1000mCi SOLUTION;ORAL Prescription None Yes Yes
SODIUM IODIDE I 131 SODIUM IODIDE I-131 2-200mCi CAPSULE;ORAL Discontinued None No No
SODIUM IODIDE I 131 SODIUM IODIDE I-131 0.009-0.1mCi CAPSULE;ORAL Prescription None Yes 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
01/24/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21305_Sodium-Iodide_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21305ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021305_sodiumiodide.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/2016 SUPPL-42 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021305Orig1s042ltr.pdf
06/15/2016 SUPPL-41 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021305s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021305Orig1s041ltr.pdf
07/31/2015 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

04/01/2016 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/26/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

12/07/2012 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/07/2012 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/03/2011 SUPPL-27 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021305s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021305s027ltr.pdf
09/23/2011 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021305s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021305s025ltr.pdf
02/29/2008 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021305s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021305s016ltr.pdf
01/17/2008 SUPPL-15 Labeling-Container/Carton Labels

Label is not available on this site.

04/18/2007 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021305s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021305s011_LTR.pdf
10/23/2006 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021305s010ltr.pdf
04/04/2006 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/06/2006 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021305s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021305s005ltr.pdf
05/19/2005 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021305s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021305s003ltr.pdf
11/18/2004 SUPPL-2 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21305s002ltr.pdf
08/08/2003 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21305slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/15/2016 SUPPL-41 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021305s041lbl.pdf
10/03/2011 SUPPL-27 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021305s027lbl.pdf
09/23/2011 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021305s025lbl.pdf
02/29/2008 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021305s016lbl.pdf
04/18/2007 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021305s011lbl.pdf
01/06/2006 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021305s005lbl.pdf
05/19/2005 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021305s003lbl.pdf
01/24/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21305_Sodium-Iodide_lbl.pdf

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