AM REGENT FDA Approval ANDA 070820

ANDA 070820

AM REGENT

FDA Drug Application

Application #070820

Application Sponsors

ANDA 070820AM REGENT

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION80MG/ML0DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1987-02-11
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1992-02-05
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1989-06-30
LABELING; LabelingSUPPL4AP1992-08-26
LABELING; LabelingSUPPL5AP1992-10-27
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1993-06-30
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1996-02-28
LABELING; LabelingSUPPL8AP1996-09-24
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-01-09
LABELING; LabelingSUPPL10AP1997-11-07
LABELING; LabelingSUPPL11AP2001-11-07
LABELING; LabelingSUPPL17AP2021-06-21STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null0
SUPPL17Null15

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70820
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOPAMINE HYDROCHLORIDE","activeIngredients":"DOPAMINE HYDROCHLORIDE","strength":"80MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOPAMINE HYDROCHLORIDE","submission":"DOPAMINE HYDROCHLORIDE","actionType":"80MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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