EPIC PHARMA LLC FDA Approval ANDA 072264

ANDA 072264

EPIC PHARMA LLC

FDA Drug Application

Application #072264

Application Sponsors

ANDA 072264EPIC PHARMA LLC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL0.5MG0BENZTROPINE MESYLATEBENZTROPINE MESYLATE

FDA Submissions

ORIG1AP1989-02-27
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1995-12-01
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1995-12-01
LABELING; LabelingSUPPL4AP1995-12-01
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1995-12-01
LABELING; LabelingSUPPL6AP1998-05-06
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1998-10-13
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2001-01-11
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2001-01-11
LABELING; LabelingSUPPL12AP2003-01-09

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0

TE Codes

001PrescriptionAA

CDER Filings

EPIC PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72264
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BENZTROPINE MESYLATE","submission":"BENZTROPINE MESYLATE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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