ANDA 210264

GLENMARK PHARMS LTD

FDA Drug Application

Application #210264

Application Sponsors

ANDA 210264

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;VAGINAL

10MCG

0

ESTRADIOL

ESTRADIOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-09-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210264
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"10MCG","dosageForm":"TABLET;VAGINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/14\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-14
        )

)