Application Sponsors
ANDA 088567 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 25MG | 0 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1984-05-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1985-10-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1985-10-08 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1985-11-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1985-11-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1985-11-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1988-05-15 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1987-10-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1988-06-09 | |
LABELING; Labeling | SUPPL | 18 | AP | 1988-04-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1988-06-09 | |
LABELING; Labeling | SUPPL | 20 | AP | 1988-07-05 | |
LABELING; Labeling | SUPPL | 21 | AP | 1990-09-17 | |
LABELING; Labeling | SUPPL | 22 | AP | 1991-02-04 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1997-01-31 | |
LABELING; Labeling | SUPPL | 24 | AP | 2015-11-03 | |
LABELING; Labeling | SUPPL | 25 | AP | 2017-02-24 | STANDARD |
Submissions Property Types
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 19 | Null | 0 |
SUPPL | 23 | Null | 0 |
SUPPL | 24 | Null | 15 |
SUPPL | 25 | Null | 7 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 88567
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)