Application Sponsors
ANDA 202349 | WATSON LABS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A | 0 | ESTRADIOL VALERATE AND DIENOGEST | DIENOGEST; ESTRADIOL VALERATE |
FDA Submissions
Submissions Property Types
TE Codes
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202349
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"ESTRADIOL VALERATE AND DIENOGEST","activeIngredients":"DIENOGEST; ESTRADIOL VALERATE","strength":"N\/A,2MG,3MG,N\/A,N\/A;3MG,2MG,2MG,1MG,N\/A","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/09\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-05-09
)
)