Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | SOLUTION;ORAL | 3.5-150mCi/VIAL | 1 | SODIUM IODIDE I 131 | SODIUM IODIDE I-131 |
| 002 | CAPSULE;ORAL | 0.8-100mCi | 0 | SODIUM IODIDE I 131 | SODIUM IODIDE I-131 |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1971-08-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1977-10-27 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1977-10-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1977-07-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1988-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1983-07-11 | |
| LABELING; Labeling | SUPPL | 10 | AP | 2012-02-03 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2014-03-20 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2015-10-20 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2018-02-06 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 12 | Null | 31 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 16 | Null | 7 |
CDER Filings
CURIUM
cder:Array
(
[0] => Array
(
[ApplNo] => 16515
[companyName] => CURIUM
[docInserts] => ["",""]
[products] => [{"drugName":"SODIUM IODIDE I 131","activeIngredients":"SODIUM IODIDE I-131","strength":"3.5-150mCi\/VIAL","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SODIUM IODIDE I 131","activeIngredients":"SODIUM IODIDE I-131","strength":"0.8-100mCi","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"02\/06\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/016515s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/016515s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/016515s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2012","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/016515s010lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"SODIUM IODIDE I 131","submission":"SODIUM IODIDE I-131","actionType":"3.5-150mCi\/VIAL","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SODIUM IODIDE I 131","submission":"SODIUM IODIDE I-131","actionType":"0.8-100mCi","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2018-02-06
)
)