GLAND PHARMA LTD FDA Approval ANDA 211920

ANDA 211920

GLAND PHARMA LTD

FDA Drug Application

Application #211920

Application Sponsors

ANDA 211920GLAND PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUS50MG/5ML (10MG/ML)0PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE
002SOLUTION;INTRAVENOUS100MG/10ML (10MG/ML)0PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-05STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP1
002PrescriptionAP1

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211920
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PHENYLEPHRINE HYDROCHLORIDE","activeIngredients":"PHENYLEPHRINE HYDROCHLORIDE","strength":"100MG\/10ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/05\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-05
        )

)

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