Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 50% | 0 | HYPAQUE | DIATRIZOATE SODIUM |
| 002 | SOLUTION;URETERAL | 20% | 0 | HYPAQUE SODIUM 20% | DIATRIZOATE SODIUM |
| 003 | INJECTABLE;INJECTION | 25% | 0 | HYPAQUE | DIATRIZOATE SODIUM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1954-11-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 1976-02-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 23 | AP | 1976-06-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 24 | AP | 1976-05-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1976-09-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1976-06-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1976-05-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1976-09-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 31 | AP | 1977-02-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 33 | AP | 1978-10-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1977-12-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1978-01-31 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1978-02-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1979-02-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1979-01-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1979-10-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 40 | AP | 1982-06-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1981-04-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1986-08-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1982-01-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 45 | AP | 1984-02-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 46 | AP | 1984-04-05 | PRIORITY |
| LABELING; Labeling | SUPPL | 47 | AP | 1982-02-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 48 | AP | 1987-02-01 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1982-03-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1983-08-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 1982-10-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1985-01-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1987-03-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1988-05-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 57 | AP | 1985-04-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 58 | AP | 1985-06-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 1986-08-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 60 | AP | 1986-03-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 61 | AP | 1986-06-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1990-02-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 63 | AP | 1986-11-07 | PRIORITY |
| LABELING; Labeling | SUPPL | 64 | AP | 1987-08-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 66 | AP | 1988-02-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 1989-04-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 68 | AP | 1989-05-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 69 | AP | 1989-05-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 70 | AP | 1989-06-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 71 | AP | 1991-10-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 72 | AP | 1991-10-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 73 | AP | 1991-10-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 75 | AP | 1993-10-05 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 76 | AP | 1996-08-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 77 | AP | 1995-06-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 78 | AP | 1998-08-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 79 | AP | 2001-08-13 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 0 |
| SUPPL | 58 | Null | 0 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 60 | Null | 0 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 62 | Null | 0 |
| SUPPL | 63 | Null | 0 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 66 | Null | 0 |
| SUPPL | 67 | Null | 0 |
| SUPPL | 68 | Null | 0 |
| SUPPL | 69 | Null | 0 |
| SUPPL | 70 | Null | 0 |
| SUPPL | 71 | Null | 0 |
| SUPPL | 72 | Null | 0 |
| SUPPL | 73 | Null | 0 |
| SUPPL | 75 | Null | 0 |
| SUPPL | 76 | Null | 0 |
| SUPPL | 77 | Null | 0 |
| SUPPL | 78 | Null | 0 |
| SUPPL | 79 | Null | 0 |
CDER Filings
GE HEALTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 9561
[companyName] => GE HEALTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"HYPAQUE","activeIngredients":"DIATRIZOATE SODIUM","strength":"50%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYPAQUE","activeIngredients":"DIATRIZOATE SODIUM","strength":"25%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYPAQUE SODIUM 20%","activeIngredients":"DIATRIZOATE SODIUM","strength":"20%","dosageForm":"SOLUTION;URETERAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYPAQUE","submission":"DIATRIZOATE SODIUM","actionType":"50%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYPAQUE","submission":"DIATRIZOATE SODIUM","actionType":"25%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYPAQUE SODIUM 20%","submission":"DIATRIZOATE SODIUM","actionType":"20%","submissionClassification":"SOLUTION;URETERAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)