ANDA 210323

CIPLA

FDA Drug Application

Application #210323

Application Sponsors

ANDA 210323

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

EXEMESTANE

EXEMESTANE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-04-27	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-06-15	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210323
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXEMESTANE","activeIngredients":"EXEMESTANE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/22\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-02-22
        )

)