ANDA 213547

QILU

FDA Drug Application

Application #213547

Application Sponsors

ANDA 213547

QILU

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

EXEMESTANE

EXEMESTANE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-04-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-05-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AB

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213547
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXEMESTANE","activeIngredients":"EXEMESTANE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/13\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-13
        )

)