Application Sponsors
| ANDA 089603 | ANI PHARMS INC | |
Marketing Status
Application Products
| 001 | CONCENTRATE;ORAL | 100MG/ML | 0 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1987-11-09 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1992-04-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-05-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1999-03-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1999-06-17 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 89603
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"100MG\/ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)