AM REGENT FDA Approval ANDA 214775

ANDA 214775

AM REGENT

FDA Drug Application

Application #214775

Application Sponsors

ANDA 214775AM REGENT

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.2MG/ML0ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-10-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214775
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOPROTERENOL HYDROCHLORIDE","activeIngredients":"ISOPROTERENOL HYDROCHLORIDE","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/19\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-19
        )

)

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