Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 500MG | 0 | TELEPAQUE | IOPANOIC ACID |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1951-07-16 | PRIORITY |
LABELING; Labeling | SUPPL | 9 | AP | 1976-10-18 | PRIORITY |
LABELING; Labeling | SUPPL | 10 | AP | 1976-10-15 | PRIORITY |
LABELING; Labeling | SUPPL | 11 | AP | 1976-10-15 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1976-10-15 | PRIORITY |
LABELING; Labeling | SUPPL | 13 | AP | 1978-10-12 | PRIORITY |
LABELING; Labeling | SUPPL | 15 | AP | 1979-11-27 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1983-09-30 | PRIORITY |
LABELING; Labeling | SUPPL | 18 | AP | 1984-03-14 | PRIORITY |
LABELING; Labeling | SUPPL | 19 | AP | 1985-04-19 | PRIORITY |
LABELING; Labeling | SUPPL | 20 | AP | 1985-11-23 | PRIORITY |
LABELING; Labeling | SUPPL | 21 | AP | 1986-07-01 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1987-05-20 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1990-05-02 | 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 | 13 | Null | 0 |
SUPPL | 15 | 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 |
CDER Filings
GE HEALTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 8032
[companyName] => GE HEALTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"TELEPAQUE","activeIngredients":"IOPANOIC ACID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TELEPAQUE","submission":"IOPANOIC ACID","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)