Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 55% | 0 | VISIPAQUE 270 | IODIXANOL |
| 002 | INJECTABLE;INJECTION | 65.2% | 0 | VISIPAQUE 320 | IODIXANOL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1997-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2003-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2003-12-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2013-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2015-07-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2017-04-05 | PRIORITY |
| LABELING; Labeling | SUPPL | 26 | AP | 2017-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2019-03-12 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2022-02-18 | STANDARD |
Submissions Property Types
| SUPPL | 2 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 32 | Null | 15 |
CDER Filings
GE HEALTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 20808
[companyName] => GE HEALTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"VISIPAQUE 270","activeIngredients":"IODIXANOL","strength":"55%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VISIPAQUE 320","activeIngredients":"IODIXANOL","strength":"65.2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"03\/12\/2019","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020351s048,020808s028lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020808s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-25","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020808s025lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020351s043,020808s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2003","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20808slr004_visipaque_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"VISIPAQUE 270","submission":"IODIXANOL","actionType":"55%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"VISIPAQUE 320","submission":"IODIXANOL","actionType":"65.2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2019-03-12
)
)