ANDA 204703

MYLAN LABS LTD

FDA Drug Application

Application #204703

Application Sponsors

ANDA 204703

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.035MG;1MG

0

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-07-28
LABELING; Labeling	SUPPL	4	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204703
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE","strength":"0.035MG;1MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/09\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-08-09
        )

)