ANDA 203339

LUPIN LTD

FDA Drug Application

Application #203339

Application Sponsors

ANDA 203339

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	0.5MG;0.1MG	0	AMABELZ	ESTRADIOL; NORETHINDRONE ACETATE
002	TABLET;ORAL	1MG;0.5MG	0	AMABELZ	ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-06-20

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203339
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMABELZ","activeIngredients":"ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.5MG;0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMABELZ","activeIngredients":"ESTRADIOL; NORETHINDRONE ACETATE","strength":"1MG;0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/20\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/21\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-04-21
        )

)