ANDA 203164

GLENMARK PHARMS LTD

FDA Drug Application

Application #203164

Application Sponsors

ANDA 203164

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.03MG;0.15MG

0

LEVONORGESTREL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-06-12
LABELING; Labeling	SUPPL	2	AP	2021-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203164
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG;0.15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/12\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-06-12
        )

)