CIPLA FDA Approval ANDA 210323

ANDA 210323

CIPLA

FDA Drug Application

Application #210323

Application Sponsors

ANDA 210323CIPLA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL25MG0EXEMESTANEEXEMESTANE

FDA Submissions

UNKNOWN; ORIG1AP2018-04-27STANDARD
LABELING; LabelingSUPPL5AP2022-06-15STANDARD

Submissions Property Types

ORIG1Null15
SUPPL5Null15

TE Codes

001PrescriptionAB

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
        )

)

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