AUROLIFE PHARMA LLC FDA Approval ANDA 070470

ANDA 070470

AUROLIFE PHARMA LLC

FDA Drug Application

Application #070470

Application Sponsors

ANDA 070470AUROLIFE PHARMA LLC

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORALEQ 100MG BASE0DISOPYRAMIDE PHOSPHATEDISOPYRAMIDE PHOSPHATE

FDA Submissions

ORIG1AP1985-12-10
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1987-03-03
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1987-03-03
LABELING; LabelingSUPPL5AP1988-03-09
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1988-11-01
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1988-11-01
LABELING; LabelingSUPPL8AP1990-12-27
LABELING; LabelingSUPPL9AP1991-09-09
LABELING; LabelingSUPPL10AP1992-02-18
LABELING; LabelingSUPPL11AP1993-04-07
LABELING; LabelingSUPPL12AP1993-06-21
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1995-02-23
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1997-08-11

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL6Null0
SUPPL7Null0
SUPPL13Null0
SUPPL14Null0

CDER Filings

AUROLIFE PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70470
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DISOPYRAMIDE PHOSPHATE","activeIngredients":"DISOPYRAMIDE PHOSPHATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DISOPYRAMIDE PHOSPHATE","submission":"DISOPYRAMIDE PHOSPHATE","actionType":"EQ 100MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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