SANDOZ INC FDA Approval ANDA 202719

ANDA 202719

SANDOZ INC

FDA Drug Application

Application #202719

Application Sponsors

ANDA 202719SANDOZ INC

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;TOPICAL0.03%0BIMATOPROSTBIMATOPROST

FDA Submissions

UNKNOWN; ORIG1AP2016-04-19
LABELING; LabelingSUPPL2AP2022-11-08STANDARD
LABELING; LabelingSUPPL5AP2022-11-08STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL5Null7

TE Codes

001PrescriptionAT

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202719
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIMATOPROST","activeIngredients":"BIMATOPROST","strength":"0.03%","dosageForm":"SOLUTION\/DROPS;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-04-19
        )

)

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