NOVITIUM PHARMA FDA Approval ANDA 214721

ANDA 214721

NOVITIUM PHARMA

FDA Drug Application

Application #214721

Application Sponsors

ANDA 214721NOVITIUM PHARMA

Marketing Status

Prescription001

Application Products

001SYRUP;ORAL10MG/5ML0DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-23STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

NOVITIUM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214721
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICYCLOMINE HYDROCHLORIDE","activeIngredients":"DICYCLOMINE HYDROCHLORIDE","strength":"10MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-23
        )

)

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