ANDA 209548

NOVAST LABS

FDA Drug Application

Application #209548

Application Sponsors

ANDA 209548

NOVAST LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.035MG;1MG

0

LO-MALMOREDE

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209548
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LO-MALMOREDE","activeIngredients":"ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE","strength":"0.035MG;1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/11\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-11
        )

)