Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 62.3% | 1 | ULTRAVIST (PHARMACY BULK) | IOPROMIDE |
| 002 | INJECTABLE;INJECTION | 76.9% | 1 | ULTRAVIST (PHARMACY BULK) | IOPROMIDE |
| 003 | INJECTABLE;INJECTION | 49.9% | 1 | ULTRAVIST (PHARMACY BULK) | IOPROMIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2002-09-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2004-03-12 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2007-08-31 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2010-06-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2009-11-13 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2012-05-02 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2015-07-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2016-11-17 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2017-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2018-04-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2018-05-04 | N/A |
| LABELING; Labeling | SUPPL | 30 | AP | 2019-08-01 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2022-02-18 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 0 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 15 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 29 | Null | 31 |
| SUPPL | 30 | Null | 6 |
| SUPPL | 34 | Null | 6 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21425
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)