ANDA 206807

ACCORD HLTHCARE

FDA Drug Application

Application #206807

Application Sponsors

ANDA 206807

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.35MG

0

NORETHINDRONE

NORETHINDRONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-12-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-09-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AB1

CDER Filings

NAARI PTE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206807
            [companyName] => NAARI PTE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHINDRONE","activeIngredients":"NORETHINDRONE","strength":"0.35MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/13\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-13
        )

)