ANDA 091690

NOVAST LABS

FDA Drug Application

Application #091690

Application Sponsors

ANDA 091690

NOVAST LABS

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

0.03MG,0.01MG; 0.15MG,N/A

0

ETHINYL ESTRADIOL AND LEVONORGESTREL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

ORIG

1

TA

2015-12-16

Submissions Property Types

ORIG

1

Null

17

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91690
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETHINYL ESTRADIOL AND LEVONORGESTREL","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG,0.01MG; 0.15MG,N\/A","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ETHINYL ESTRADIOL AND LEVONORGESTREL","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.03MG,0.01MG; 0.15MG,N\/A","submissionClassification":"TABLET;ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)