Documents
Application Sponsors
| NDA 020937 | LIEBEL-FLARSHEIM | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 1654.5MG/5ML (330.9MG/ML) | 1 | OPTIMARK | GADOVERSETAMIDE |
| 002 | INJECTABLE;INJECTION | 3309MG/10ML (330.9MG/ML) | 1 | OPTIMARK | GADOVERSETAMIDE |
| 003 | INJECTABLE;INJECTION | 4963.5MG/15ML (330.9MG/ML) | 1 | OPTIMARK | GADOVERSETAMIDE |
| 004 | INJECTABLE;INJECTION | 6618MG/20ML (330.9MG/ML) | 1 | OPTIMARK | GADOVERSETAMIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1999-12-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-01-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2003-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2005-11-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2006-08-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 11 | AP | 2007-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2010-12-20 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2012-12-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2013-05-06 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2013-05-21 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2013-08-26 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2014-08-07 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2014-11-24 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2016-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2016-08-29 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2018-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2018-11-02 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 28 | Null | 6 |
CDER Filings
LIEBEL-FLARSHEIM
cder:Array
(
[0] => Array
(
[ApplNo] => 20937
[companyName] => LIEBEL-FLARSHEIM
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/020937s028,020975s029,020976s030lbl.pdf#page=14"]
[products] => [{"drugName":"OPTIMARK","activeIngredients":"GADOVERSETAMIDE","strength":"1654.5MG\/5ML (330.9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OPTIMARK","activeIngredients":"GADOVERSETAMIDE","strength":"3309MG\/10ML (330.9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OPTIMARK","activeIngredients":"GADOVERSETAMIDE","strength":"4963.5MG\/15ML (330.9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OPTIMARK","activeIngredients":"GADOVERSETAMIDE","strength":"6618MG\/20ML (330.9MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020937s028,020975s029,020976s030lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2018","submission":"SUPPL-27","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020937s027lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2018","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020937s027lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2016","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020937s026,020975s027,020976s028lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2014","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/2014\\\/020937s02420975s2520976s26lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2014","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020937s023,020975s024,020976s025lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2013","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020937s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2013","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020937s021,020975s022,020976s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2010","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020937s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2007","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020937s011,020976s011,020975s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2006","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020937,020975,020976s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2003","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2003\\\/20-937S003_OptiMark_Prntlbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/20937_OptiMark_prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"OPTIMARK","submission":"GADOVERSETAMIDE","actionType":"1654.5MG\/5ML (330.9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OPTIMARK","submission":"GADOVERSETAMIDE","actionType":"3309MG\/10ML (330.9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OPTIMARK","submission":"GADOVERSETAMIDE","actionType":"4963.5MG\/15ML (330.9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OPTIMARK","submission":"GADOVERSETAMIDE","actionType":"6618MG\/20ML (330.9MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-11-02
)
)