Application Sponsors
| ANDA 081030 | SUN PHARM INDUSTRIES | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 200MG | 0 | QUINIDINE SULFATE | QUINIDINE SULFATE |
FDA Submissions
| ORIG | 1 | AP | 1989-04-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-06-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1995-06-22 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1996-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-10-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1997-02-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1997-12-05 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1999-01-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2000-05-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2001-05-16 | |
| LABELING; Labeling | SUPPL | 26 | AP | 2010-02-02 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 26 | Null | 7 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 81030
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"QUINIDINE SULFATE","activeIngredients":"QUINIDINE SULFATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"QUINIDINE SULFATE","submission":"QUINIDINE SULFATE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)