Application Sponsors
ANDA 088456 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 100MG | 0 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1985-05-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-03-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-03-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1986-04-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1986-04-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1987-10-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1994-10-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-02-16 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
CDER Filings
ANI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 88456
[companyName] => ANI PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)