Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016517
Company: CURIUM
Company: CURIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM IODIDE I 131 | SODIUM IODIDE I-131 | 0.8-100mCi | CAPSULE;ORAL | Discontinued | None | Yes | No |
SODIUM IODIDE I 131 | SODIUM IODIDE I-131 | 15-100uCi | 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 |
---|---|---|---|---|---|---|---|
08/20/1971 | 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/2018/016517s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016517Orig1s016ltr.pdf | |
10/20/2015 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016517s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016517Orig1s013ltr.pdf | |
10/23/2014 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/20/2014 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016517s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016517Orig1s011ltr.pdf | |
02/03/2012 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016517s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016517s009ltr.pdf | |
07/12/1983 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
08/23/1977 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/29/1977 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/03/1977 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
01/16/1976 | 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/2018/016517s016lbl.pdf | |
10/20/2015 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016517s013lbl.pdf | |
03/20/2014 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016517s011lbl.pdf | |
02/03/2012 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016517s009lbl.pdf |