AM REGENT FDA Approval ANDA 072123

ANDA 072123

AM REGENT

FDA Drug Application

Application #072123

Application Sponsors

ANDA 072123AM REGENT

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION2.5MG/ML0DROPERIDOLDROPERIDOL

FDA Submissions

ORIG1AP1988-10-24
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1995-05-26
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1994-10-11
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1996-02-28
LABELING; LabelingSUPPL5AP1995-02-17
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1998-07-02
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1999-03-25
LABELING; LabelingSUPPL12AP2002-01-10

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL7Null0
SUPPL8Null0

TE Codes

001PrescriptionAP

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72123
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROPERIDOL","activeIngredients":"DROPERIDOL","strength":"2.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DROPERIDOL","submission":"DROPERIDOL","actionType":"2.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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