Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 14.35GM/50ML (287MG/ML) | 0 | OMNISCAN | GADODIAMIDE |
| 002 | INJECTABLE;INJECTION | 28.7GM/100ML (287MG/ML) | 1 | OMNISCAN | GADODIAMIDE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2007-09-05 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2010-12-20 | UNKNOWN |
| LABELING; Labeling | SUPPL | 4 | AP | 2013-08-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2014-05-14 | N/A |
| LABELING; Labeling | SUPPL | 6 | AP | 2012-12-11 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2014-11-14 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2018-04-26 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-11-07 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-10-23 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 7 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 4 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 31 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 6 |
CDER Filings
GE HEALTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 22066
[companyName] => GE HEALTHCARE
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/022066s008lbl.pdf#page=1"]
[products] => [{"drugName":"OMNISCAN","activeIngredients":"GADODIAMIDE","strength":"14.35GM\/50ML (287MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMNISCAN","activeIngredients":"GADODIAMIDE","strength":"28.7GM\/100ML (287MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/23\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022066s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020123s047,022066s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022066s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2014","submission":"SUPPL-7","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022066s007,020123s043lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022066s00420123s039lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2010","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022066s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022066lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"OMNISCAN","submission":"GADODIAMIDE","actionType":"14.35GM\/50ML (287MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OMNISCAN","submission":"GADODIAMIDE","actionType":"28.7GM\/100ML (287MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-10-23
)
)