ANDA 202349

WATSON LABS INC

FDA Drug Application

Application #202349

Application Sponsors

ANDA 202349

WATSON LABS INC

Marketing Status

• Prescription: 001

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

ORIG

1

TA

2017-05-09

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB

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
        )

)