ANDA 207066

ACCORD HLTHCARE

FDA Drug Application

Application #207066

Application Sponsors

ANDA 207066

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET, CHEWABLE;ORAL

0.035MG;0.4MG

0

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

ETHINYL ESTRADIOL; NORETHINDRONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-03-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

NAARI PTE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207066
            [companyName] => NAARI PTE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE","strength":"0.035MG;0.4MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/29\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-29
        )

)