Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL-28 | 0.35MG | 0 | NORETHINDRONE | NORETHINDRONE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2013-09-13 | |
Submissions Property Types
TE Codes
CDER Filings
NOVAST LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 200961
[companyName] => NOVAST LABS
[docInserts] => ["",""]
[products] => [{"drugName":"NORETHINDRONE","activeIngredients":"NORETHINDRONE","strength":"0.35MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/13\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/29\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2014-08-29
)
)