ANDA 207067

ACCORD HLTHCARE

FDA Drug Application

Application #207067

Application Sponsors

ANDA 207067

ACCORD HLTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL-28

0.15MG;0.03MG

0

DESOGESTREL AND ETHINYL ESTRADIOL

DESOGESTREL; ETHINYL ESTRADIOL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-09-13	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

CDER Filings

NAARI PTE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207067
            [companyName] => NAARI PTE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESOGESTREL AND ETHINYL ESTRADIOL","activeIngredients":"DESOGESTREL; ETHINYL ESTRADIOL","strength":"0.15MG;0.03MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-13
        )

)