Documents
Application Sponsors
| NDA 020923 | LIEBEL-FLARSHEIM | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 51% | 0 | OPTIRAY 240 | IOVERSOL |
| 002 | INJECTABLE;INJECTION | 68% | 1 | OPTIRAY 320 | IOVERSOL |
| 003 | INJECTABLE;INJECTION | 74% | 1 | OPTIRAY 350 | IOVERSOL |
| 004 | INJECTABLE;INJECTION | 64% | 1 | OPTIRAY 300 | IOVERSOL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1998-05-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1999-07-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2001-09-12 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2009-08-08 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2016-08-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2013-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2015-07-06 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2017-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2017-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2017-12-12 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2020-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2020-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2022-02-18 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 4 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 25 | Null | 33 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 28 | Null | 7 |
CDER Filings
LIEBEL-FLARSHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 20923
[companyName] => LIEBEL-FLARSHEIM
[docInserts] => ["",""]
[products] => [{"drugName":"OPTIRAY 240","activeIngredients":"IOVERSOL","strength":"51%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OPTIRAY 300","activeIngredients":"IOVERSOL","strength":"64%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OPTIRAY 320","activeIngredients":"IOVERSOL","strength":"68%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OPTIRAY 350","activeIngredients":"IOVERSOL","strength":"74%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/18\/2020","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020923s026lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2020","submission":"SUPPL-26","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020923s026lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2020","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020923s025lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020923s021lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019710s054,020923s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020923s020lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019710s039,020923s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019710s052,020923s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20923lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"OPTIRAY 240","submission":"IOVERSOL","actionType":"51%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OPTIRAY 300","submission":"IOVERSOL","actionType":"64%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OPTIRAY 320","submission":"IOVERSOL","actionType":"68%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OPTIRAY 350","submission":"IOVERSOL","actionType":"74%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-11-18
)
)