ANDA 200383

NAARI PTE LTD

FDA Drug Application

Application #200383

Application Sponsors

ANDA 200383

NAARI PTE LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL-28

0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;0.25MG

0

NORGESTIMATE AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; NORGESTIMATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2015-04-07
LABELING; Labeling	SUPPL	2	AP	2022-02-02	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

NAARI PTE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200383
            [companyName] => NAARI PTE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORGESTIMATE AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; NORGESTIMATE","strength":"0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;0.25MG","dosageForm":"TABLET;ORAL-28","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/07\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/29\/2022","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/02\/2022","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/02\/2022","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2022-04-29
        )

)