ANDA 202380

NAARI PTE LTD

FDA Drug Application

Application #202380

Application Sponsors

ANDA 202380

NAARI PTE LTD

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

1.5MG

0

LEVONORGESTREL

LEVONORGESTREL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-05-29
LABELING; Labeling	SUPPL	4	AP	2022-10-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

CDER Filings

NAARI PTE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202380
            [companyName] => NAARI PTE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL","activeIngredients":"LEVONORGESTREL","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/29\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/13\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-09-13
        )

)