ANDA 213418

GLENMARK PHARMS LTD

FDA Drug Application

Application #213418

Application Sponsors

ANDA 213418

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.02MG;1MG

0

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-07-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213418
            [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":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-27
        )

)