ANDA 202716

JIANGSU HENGRUI MED

FDA Drug Application

Application #202716

Application Sponsors

ANDA 202716

JIANGSU HENGRUI MED

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

2.5MG

0

LETROZOLE

LETROZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-05-16
LABELING; Labeling	SUPPL	2	AP	2019-05-19	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-05-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

JIANGSU HENGRUI MED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202716
            [companyName] => JIANGSU HENGRUI MED
            [docInserts] => ["",""]
            [products] => [{"drugName":"LETROZOLE","activeIngredients":"LETROZOLE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/16\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/19\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/19\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/21\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-19
        )

)