FRESENIUS KABI USA FDA Approval ANDA 210665

ANDA 210665

FRESENIUS KABI USA

FDA Drug Application

Application #210665

Application Sponsors

ANDA 210665FRESENIUS KABI USA

Marketing Status

Prescription001

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2019-01-29STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP2

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210665
            [companyName] => FRESENIUS KABI USA
            [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":"01\/29\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-29
        )

)

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