Documents
Application Sponsors
Marketing Status
Application Products
| 001 | OIL;INTRALYMPHATIC, INTRAUTERINE | EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML) | 1 | LIPIODOL | ETHIODIZED OIL |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1954-03-31 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1978-02-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1979-11-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1979-11-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 16 | AP | 1985-09-10 | |
| LABELING; Labeling | SUPPL | 21 | AP | 2014-03-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2014-01-23 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 24 | AP | 2014-04-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2018-09-28 | N/A |
| LABELING; Labeling | SUPPL | 29 | AP | 2020-06-10 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2020-06-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 25 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 27 | Null | 15 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 31 | Null | 6 |
CDER Filings
GUERBET
cder:Array
(
[0] => Array
(
[ApplNo] => 9190
[companyName] => GUERBET
[docInserts] => ["",""]
[products] => [{"drugName":"LIPIODOL","activeIngredients":"ETHIODIZED OIL","strength":"EQ 4.8GM IODINE\/10ML (EQ 480MG IODINE\/ML)","dosageForm":"OIL;INTRALYMPHATIC, INTRAUTERINE","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/10\/2020","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/009190s029s031lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2020","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/009190s029s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2014","submission":"SUPPL-24","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/009190s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2014","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/009190s021lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"LIPIODOL","submission":"ETHIODIZED OIL","actionType":"EQ 4.8GM IODINE\/10ML (EQ 480MG IODINE\/ML)","submissionClassification":"OIL;INTRALYMPHATIC, INTRAUTERINE","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-06-10
)
)