Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 60% | 0 | HYPAQUE | DIATRIZOATE MEGLUMINE |
| 002 | INJECTABLE;INJECTION | 30% | 0 | HYPAQUE | DIATRIZOATE MEGLUMINE |
| 003 | SOLUTION;URETHRAL | 30% | 0 | HYPAQUE-CYSTO | DIATRIZOATE MEGLUMINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1969-08-21 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1975-05-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1975-05-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1975-05-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 12 | AP | 1975-08-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 1976-06-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 18 | AP | 1976-06-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1976-06-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1976-06-02 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1976-06-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 1977-04-01 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 1978-07-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1978-01-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1978-01-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1978-01-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1979-02-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1979-02-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1979-02-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1979-04-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1981-04-27 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1981-04-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1983-10-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1982-01-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 35 | AP | 1984-01-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1982-02-24 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 37 | AP | 1984-01-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 38 | AP | 1984-03-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1982-03-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1983-02-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1985-09-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 42 | AP | 1984-03-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1982-10-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1985-01-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1983-01-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1988-05-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 47 | AP | 1984-11-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 48 | AP | 1985-04-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 49 | AP | 1985-04-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 50 | AP | 1985-04-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 51 | AP | 1985-11-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 52 | AP | 1986-02-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1990-02-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 54 | AP | 1988-02-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 1989-04-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 1989-06-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 1989-06-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 58 | AP | 1989-04-18 | PRIORITY |
| LABELING; Labeling | SUPPL | 59 | AP | 1989-05-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 60 | AP | 1989-05-26 | PRIORITY |
| LABELING; Labeling | SUPPL | 61 | AP | 1989-06-28 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 62 | AP | 1989-10-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 1991-04-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 64 | AP | 1991-10-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 65 | AP | 1991-10-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 66 | AP | 1991-10-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 67 | AP | 1994-03-25 | PRIORITY |
| LABELING; Labeling | SUPPL | 68 | AP | 1995-06-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 69 | AP | 1998-08-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 70 | AP | 2001-08-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 71 | AP | 2002-09-30 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | 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 | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | 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 | 44 | 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 | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | 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 | 65 | 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 |
CDER Filings
GE HEALTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 16403
[companyName] => GE HEALTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"HYPAQUE","activeIngredients":"DIATRIZOATE MEGLUMINE","strength":"60%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYPAQUE","activeIngredients":"DIATRIZOATE MEGLUMINE","strength":"30%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYPAQUE-CYSTO","activeIngredients":"DIATRIZOATE MEGLUMINE","strength":"30%","dosageForm":"SOLUTION;URETHRAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYPAQUE","submission":"DIATRIZOATE MEGLUMINE","actionType":"60%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYPAQUE","submission":"DIATRIZOATE MEGLUMINE","actionType":"30%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYPAQUE-CYSTO","submission":"DIATRIZOATE MEGLUMINE","actionType":"30%","submissionClassification":"SOLUTION;URETHRAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)