ANDA 208097

GLENMARK PHARMS LTD

FDA Drug Application

Application #208097

Documents

• Letter: 2016-04-27

Application Sponsors

ANDA 208097

GLENMARK PHARMS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

75MG

0

NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; FERROUS FUMARATE

NORETHINDRONE ACETATE;ETHINYL ESTRADIOL;ETHINYL ESTRADIOL;FERROUS FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-04-22

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208097
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; FERROUS FUMARATE","activeIngredients":"NORETHINDRONE ACETATE;ETHINYL ESTRADIOL;ETHINYL ESTRADIOL;FERROUS FUMARATE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/22\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208097Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-04-22
        )

)