Application Sponsors
| ANDA 089590 | SUN PHARM INDUSTRIES | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | SULFASALAZINE | SULFASALAZINE |
FDA Submissions
| ORIG | 1 | AP | 1987-10-19 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1990-09-26 | |
| LABELING; Labeling | SUPPL | 3 | AP | 1991-02-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1991-04-03 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1991-05-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1994-01-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-06-22 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-10-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1997-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1997-12-05 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1998-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1998-12-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1998-11-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1998-11-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2000-05-16 | |
| LABELING; Labeling | SUPPL | 20 | AP | 2000-03-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2001-02-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2001-04-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2001-08-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2001-08-21 | |
| LABELING; Labeling | SUPPL | 25 | AP | 2001-08-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2001-11-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2002-05-15 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 89590
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"SULFASALAZINE","activeIngredients":"SULFASALAZINE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SULFASALAZINE","submission":"SULFASALAZINE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)