Application Sponsors
| ANDA 089953 | SUN PHARM INDUSTRIES | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 001 | TABLET;ORAL | 100MG | 0 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 50MG | 0 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 25MG | 0 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE |
| 004 | TABLET;ORAL | 10MG | 0 | THIORIDAZINE HYDROCHLORIDE | THIORIDAZINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1988-10-07 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1990-02-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1994-01-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1995-06-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1997-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1997-12-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-05-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-10-02 | |
| LABELING; Labeling | SUPPL | 13 | AP | 2000-10-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2001-09-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2001-09-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2002-06-25 | |
| LABELING; Labeling | SUPPL | 33 | AP | 2010-12-03 | |
| LABELING; Labeling | SUPPL | 37 | AP | 2017-02-23 | STANDARD |
Submissions Property Types
| SUPPL | 5 | 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 | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 37 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 89953
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"THIORIDAZINE HYDROCHLORIDE","activeIngredients":"THIORIDAZINE HYDROCHLORIDE","strength":"10MG","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"},{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"THIORIDAZINE HYDROCHLORIDE","submission":"THIORIDAZINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)