Application Sponsors
ANDA 088872 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 200MG | 0 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1985-04-26 | |
BIOEQUIV; Bioequivalence | SUPPL | 3 | AP | 1989-05-17 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1990-06-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1991-08-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1991-01-28 | |
LABELING; Labeling | SUPPL | 11 | AP | 1990-08-09 | |
LABELING; Labeling | SUPPL | 13 | AP | 2015-11-03 | |
LABELING; Labeling | SUPPL | 14 | AP | 2017-02-23 | STANDARD |
Submissions Property Types
SUPPL | 3 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 13 | Null | 29 |
SUPPL | 14 | Null | 7 |
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 88872
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)