CIPLA FDA Approval ANDA 091164

ANDA 091164

CIPLA

FDA Drug Application

Application #091164

Application Sponsors

ANDA 091164CIPLA

Marketing Status

Prescription001

Application Products

001TABLET;ORAL1MG0ANASTROZOLEANASTROZOLE

FDA Submissions

ORIG1AP2010-06-28
LABELING; LabelingSUPPL2AP2019-10-09STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15

TE Codes

001PrescriptionAB

CDER Filings

CIPLA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91164
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANASTROZOLE","activeIngredients":"ANASTROZOLE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ANASTROZOLE","submission":"ANASTROZOLE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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