Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 400MG;80MG | 0 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM |
FDA Submissions
| ORIG | 1 | AP | 1985-09-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1986-06-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1986-06-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1986-06-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-07-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1986-07-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1986-11-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-03-14 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1990-03-16 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1991-02-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1994-05-11 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1994-04-04 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1995-12-07 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1997-10-22 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1998-07-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1998-11-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1998-11-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2000-07-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2001-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2001-05-29 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| 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 | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
CDER Filings
PLIVA
cder:Array
(
[0] => Array
(
[ApplNo] => 70215
[companyName] => PLIVA
[docInserts] => ["",""]
[products] => [{"drugName":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","activeIngredients":"SULFAMETHOXAZOLE; TRIMETHOPRIM","strength":"400MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","submission":"SULFAMETHOXAZOLE; TRIMETHOPRIM","actionType":"400MG;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)