ANDA 204847

GLENMARK PHARMS LTD

FDA Drug Application

Application #204847

Application Sponsors

ANDA 204847

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.02MG;1MG

0

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-11-17	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-02-07	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204847
            [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;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-17
        )

)