Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021305
Company: JUBILANT
Company: JUBILANT
| 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 | AA | 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 |
|---|---|---|---|---|---|
| 06/11/2021 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021305Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021305Orig1s047ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 06/11/2021 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021305Orig1s047lbl.pdf | |
| 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 |
HICON
SOLUTION;ORAL; 250-1000mCi
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HICON | SODIUM IODIDE I-131 | 250-1000mCi | SOLUTION;ORAL | Prescription | Yes | AA | 021305 | JUBILANT |
| SODIUM IODIDE I 131 | SODIUM IODIDE I-131 | 250-1000mCi | SOLUTION;ORAL | Prescription | No | AA | 209166 | INTL ISOTOPES |
SODIUM IODIDE I 131
There are no Therapeutic Equivalents.