Application Sponsors
| ANDA 202581 | MYLAN PHARMS INC | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 324MG | 0 | QUININE SULFATE | QUININE SULFATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2012-12-14 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2013-07-11 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2015-12-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202581
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"QUININE SULFATE","activeIngredients":"QUININE SULFATE","strength":"324MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/14\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/04\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/11\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/23\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-12-04
)
)