Application Sponsors
| ANDA 083982 | SUN PHARM INDUSTRIES | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | PROPYLTHIOURACIL | PROPYLTHIOURACIL |
FDA Submissions
| ORIG | 1 | AP | 1974-05-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1983-02-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1983-02-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1985-10-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1986-09-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1987-04-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1988-02-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1988-02-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1988-02-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1988-02-22 | |
| LABELING; Labeling | SUPPL | 39 | AP | 1988-10-28 | |
| LABELING; Labeling | SUPPL | 40 | AP | 1990-06-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1992-04-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1992-04-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1994-10-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1994-12-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 46 | AP | 1998-12-01 | |
Submissions Property Types
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
| SUPPL | 46 | Null | 0 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 83982
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"PROPYLTHIOURACIL","activeIngredients":"PROPYLTHIOURACIL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PROPYLTHIOURACIL","submission":"PROPYLTHIOURACIL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)