Documents
Application Sponsors
| ANDA 087014 | ORGANON USA INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 25MG/ML | 0 | ORGATRAX | HYDROXYZINE HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | 50MG/ML | 0 | ORGATRAX | HYDROXYZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1980-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1982-07-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1982-07-23 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2014-06-26 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2014-11-28 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 7 |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 87014
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"ORGATRAX","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ORGATRAX","activeIngredients":"HYDROXYZINE HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ORGATRAX","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"25MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ORGATRAX","submission":"HYDROXYZINE HYDROCHLORIDE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)