Application Sponsors
ANDA 202778 | MYLAN PHARMS INC | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | EQ 150MG BASE | 0 | DOXYCYCLINE | DOXYCYCLINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2012-06-08 | |
LABELING; Labeling | SUPPL | 3 | AP | 2014-06-17 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2014-11-26 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 7 |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202778
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"DOXYCYCLINE","activeIngredients":"DOXYCYCLINE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/08\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/26\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/17\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2014-11-26
)
)