ANDA 208639

APOTEX

FDA Drug Application

Application #208639

Application Sponsors

ANDA 208639

APOTEX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.02MG;1MG

0

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-03-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208639
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.02MG;1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-21
        )

)