Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | 1.8143GM/10ML (181.43MG/ML) | 1 | EOVIST | GADOXETATE DISODIUM |
| 002 | SOLUTION;INTRAVENOUS | 2.72145GM/15ML (181.43MG/ML) | 1 | EOVIST | GADOXETATE DISODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2008-07-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2009-11-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2013-02-04 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2010-12-20 | UNKNOWN |
| LABELING; Labeling | SUPPL | 5 | AP | 2011-11-16 | UNKNOWN |
| LABELING; Labeling | SUPPL | 8 | AP | 2013-10-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2014-01-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2015-03-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2015-10-26 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2018-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2018-07-26 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2018-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2021-12-01 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2021-12-28 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 7 |
CDER Filings
BAYER HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 22090
[companyName] => BAYER HLTHCARE
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/022090s020lbledt.pdf#page=15"]
[products] => [{"drugName":"EOVIST","activeIngredients":"GADOXETATE DISODIUM","strength":"1.8143GM\/10ML (181.43MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"EOVIST","activeIngredients":"GADOXETATE DISODIUM","strength":"2.72145GM\/15ML (181.43MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/28\/2021","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022090s020lbledt.pdf\"}]","notes":""},{"actionDate":"12\/01\/2021","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022090Orig1s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022090s016lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022090s015,201277s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022090s015,201277s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022090s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2015","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022090s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022090s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2011","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022090s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2010","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022090s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022090lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"EOVIST","submission":"GADOXETATE DISODIUM","actionType":"1.8143GM\/10ML (181.43MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"EOVIST","submission":"GADOXETATE DISODIUM","actionType":"2.72145GM\/15ML (181.43MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-12-28
)
)