ANDA 205947

LUPIN LTD

FDA Drug Application

Application #205947

Application Sponsors

ANDA 205947

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

3MG,N/A;0.02MG,N/A;0.451MG,0.451MG

0

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2020-08-12	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205947
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM","activeIngredients":"DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM","strength":"3MG,N\/A;0.02MG,N\/A;0.451MG,0.451MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/13\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/12\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-12
        )

)