WATSON LABS TEVA FDA Approval ANDA 072163

ANDA 072163

WATSON LABS TEVA

FDA Drug Application

Application #072163

Application Sponsors

ANDA 072163WATSON LABS TEVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL50MG0MAPROTILINE HYDROCHLORIDEMAPROTILINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1988-06-01
LABELING; LabelingSUPPL2AP1990-11-29
LABELING; LabelingSUPPL3AP1992-05-20
LABELING; LabelingSUPPL4AP1992-06-04
LABELING; LabelingSUPPL5AP1998-08-26
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-11-10
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-11-07
LABELING; LabelingSUPPL9AP2014-07-17STANDARD

Submissions Property Types

SUPPL6Null0
SUPPL7Null0
SUPPL9Null15

CDER Filings

HERITAGE PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72163
            [companyName] => HERITAGE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAPROTILINE HYDROCHLORIDE","activeIngredients":"MAPROTILINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MAPROTILINE HYDROCHLORIDE","submission":"MAPROTILINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.