HAINAN POLY FDA Approval ANDA 216131

ANDA 216131

HAINAN POLY

FDA Drug Application

Application #216131

Application Sponsors

ANDA 216131HAINAN POLY

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 12.5MG BASE/ML0DOBUTAMINE HYDROCHLORIDEDOBUTAMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-12-21STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

HAINAN POLY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216131
            [companyName] => HAINAN POLY
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOBUTAMINE HYDROCHLORIDE","activeIngredients":"DOBUTAMINE HYDROCHLORIDE","strength":"EQ 12.5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOBUTAMINE HYDROCHLORIDE","submission":"DOBUTAMINE HYDROCHLORIDE","actionType":"EQ 12.5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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