ACCORD HLTHCARE FDA Approval ANDA 213424

ANDA 213424

ACCORD HLTHCARE

FDA Drug Application

Application #213424

Documents

Letter2021-04-13

Application Sponsors

ANDA 213424ACCORD HLTHCARE

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL8MG/20ML (0.4MG/ML)0ATROPINE SULFATEATROPINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2021-03-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213424
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"8MG\/20ML (0.4MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATROPINE SULFATE","submission":"ATROPINE SULFATE","actionType":"8MG\/20ML (0.4MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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