Documents
Application Sponsors
| NDA 019710 | LIEBEL-FLARSHEIM | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | INJECTABLE;INJECTION | 68% | 1 | OPTIRAY 320 | IOVERSOL |
| 002 | INJECTABLE;INJECTION | 51% | 1 | OPTIRAY 240 | IOVERSOL |
| 003 | INJECTABLE;INJECTION | 34% | 0 | OPTIRAY 160 | IOVERSOL |
| 004 | INJECTABLE;INJECTION | 64% | 1 | OPTIRAY 300 | IOVERSOL |
| 005 | INJECTABLE;INJECTION | 74% | 1 | OPTIRAY 350 | IOVERSOL |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1988-12-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1989-10-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1990-03-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 1992-01-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1992-01-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 1992-07-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1992-12-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1992-08-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1993-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1992-10-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 12 | AP | 1992-12-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1996-07-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 1993-03-09 | |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 1993-07-27 | |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 1995-06-21 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1995-01-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1997-05-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1999-03-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1999-04-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1999-10-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2001-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2001-09-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2001-08-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2006-03-15 | N/A |
| LABELING; Labeling | SUPPL | 32 | AP | 2008-04-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2007-08-28 | N/A |
| LABELING; Labeling | SUPPL | 34 | AP | 2008-04-25 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2009-08-08 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2016-08-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 2013-12-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 2013-12-06 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2015-07-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 2016-05-13 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2017-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2017-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 58 | AP | 2020-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2022-05-04 | STANDARD |
| LABELING; Labeling | SUPPL | 65 | AP | 2022-02-18 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 39 | Null | 6 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 15 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 15 |
| SUPPL | 55 | Null | 6 |
| SUPPL | 58 | Null | 15 |
| SUPPL | 64 | Null | 7 |
| SUPPL | 65 | Null | 6 |
CDER Filings
LIEBEL-FLARSHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 19710
[companyName] => LIEBEL-FLARSHEIM
[docInserts] => ["",""]
[products] => [{"drugName":"OPTIRAY 160","activeIngredients":"IOVERSOL","strength":"34%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OPTIRAY 240","activeIngredients":"IOVERSOL","strength":"51%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"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":"01\/23\/2020","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/019710s058lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2017","submission":"SUPPL-54","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-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019710s055lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2016","submission":"SUPPL-39","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-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/019710s052,020923s018lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"OPTIRAY 160","submission":"IOVERSOL","actionType":"34%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OPTIRAY 240","submission":"IOVERSOL","actionType":"51%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"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] => 2020-01-23
)
)