ANDA 210369

GLENMARK PHARMS LTD

FDA Drug Application

Application #210369

Application Sponsors

ANDA 210369

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, CHEWABLE;ORAL

0.02MG;1MG

0

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210369
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.02MG;1MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/29\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Proprietary Name Change","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-05-29
        )

)