AUROBINDO PHARMA LTD FDA Approval ANDA 210696

ANDA 210696

AUROBINDO PHARMA LTD

FDA Drug Application

Application #210696

Application Sponsors

ANDA 210696AUROBINDO PHARMA LTD

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS10MG/ML (10MG/ML)0PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-07STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP2

CDER Filings

AUROBINDO PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210696
            [companyName] => AUROBINDO PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"10MG\/ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENYLEPHRINE HYDROCHLORIDE","submission":"PHENYLEPHRINE HYDROCHLORIDE","actionType":"10MG\/ML (10MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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