APOTEX INC FDA Approval ANDA 215624

ANDA 215624

APOTEX INC

FDA Drug Application

Application #215624

Documents

Letter2021-12-20

Application Sponsors

ANDA 215624APOTEX INC

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC1%0ATROPINE SULFATEATROPINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAT

CDER Filings

APOTEX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215624
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-26
        )

)

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