Application Sponsors
| ANDA 088738 | SUN PHARM INDUSTRIES | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 200MG | 0 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1984-10-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1986-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-07-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1986-07-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1987-04-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1987-10-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1987-10-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1987-12-28 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1988-06-02 | |
| LABELING; Labeling | SUPPL | 14 | AP | 1988-08-19 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1990-02-23 | |
| BIOEQUIV; Bioequivalence | SUPPL | 16 | AP | 1990-04-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1992-04-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1992-04-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1994-10-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1994-12-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1998-12-01 | |
| LABELING; Labeling | SUPPL | 23 | AP | 2010-12-03 | |
| LABELING; Labeling | SUPPL | 24 | AP | 2017-02-23 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 88738
[companyName] => SUN PHARM INDUSTRIES
[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
)
)