Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | TABLET;ORAL | 1MG;0.01MG;75MG | 0 | LO-BLISOVI FE | NORETHINDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2014-05-12 | |
Submissions Property Types
CDER Filings
LUPIN LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203113
[companyName] => LUPIN LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LO-BLISOVI FE","activeIngredients":"NORETHINDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATE","strength":"1MG;0.01MG;75MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/12\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2014-05-12
)
)