PLIVA FDA Approval ANDA 088888

ANDA 088888

PLIVA

FDA Drug Application

Application #088888

Application Sponsors

ANDA 088888PLIVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL150MG0AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1984-09-26
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1985-06-17
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1985-06-17
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1988-03-22
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1991-07-29
BIOEQUIV; BioequivalenceSUPPL7AP1990-02-14
LABELING; LabelingSUPPL8AP1990-11-16
LABELING; LabelingSUPPL10AP1992-05-26
LABELING; LabelingSUPPL11AP1993-11-04
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1994-05-11
LABELING; LabelingSUPPL13AP1995-07-14
LABELING; LabelingSUPPL14AP1995-05-24
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2000-07-07
LABELING; LabelingSUPPL16AP2000-10-05
LABELING; LabelingSUPPL18AP2001-06-25

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL18Null0

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88888
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMITRIPTYLINE HYDROCHLORIDE","activeIngredients":"AMITRIPTYLINE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMITRIPTYLINE HYDROCHLORIDE","submission":"AMITRIPTYLINE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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