Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | INJECTABLE;INJECTION | 3.75GM/VIAL | 0 | AMIPAQUE | METRIZAMIDE |
| 002 | INJECTABLE;INJECTION | 6.75GM/VIAL | 0 | AMIPAQUE | METRIZAMIDE |
| 003 | INJECTABLE;INJECTION | 2.5GM/VIAL | 0 | AMIPAQUE | METRIZAMIDE |
| 004 | INJECTABLE;INJECTION | 13.5GM/VIAL | 0 | AMIPAQUE | METRIZAMIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1978-08-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 1980-02-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 1980-02-29 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 1983-01-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1981-11-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1981-10-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 1982-07-09 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 1983-09-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1983-01-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1983-09-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1988-05-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 1987-08-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 23 | AP | 1986-11-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 24 | AP | 1989-05-31 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
CDER Filings
GE HEALTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 17982
[companyName] => GE HEALTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"AMIPAQUE","activeIngredients":"METRIZAMIDE","strength":"3.75GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMIPAQUE","activeIngredients":"METRIZAMIDE","strength":"6.75GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMIPAQUE","activeIngredients":"METRIZAMIDE","strength":"2.5GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMIPAQUE","activeIngredients":"METRIZAMIDE","strength":"13.5GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AMIPAQUE","submission":"METRIZAMIDE","actionType":"3.75GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMIPAQUE","submission":"METRIZAMIDE","actionType":"6.75GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMIPAQUE","submission":"METRIZAMIDE","actionType":"2.5GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMIPAQUE","submission":"METRIZAMIDE","actionType":"13.5GM\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)