UPSHER SMITH LABS FDA Approval ANDA 072943

ANDA 072943

UPSHER SMITH LABS

FDA Drug Application

Application #072943

Application Sponsors

ANDA 072943UPSHER SMITH LABS

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL25MG0AMOXAPINEAMOXAPINE

FDA Submissions

ORIG1AP1991-06-28
LABELING; LabelingSUPPL2AP1993-07-29
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1994-01-24
LABELING; LabelingSUPPL4AP1995-04-10
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1997-09-17
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-05-05
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2001-03-23
LABELING; LabelingSUPPL8AP2001-05-22
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2002-03-25
LABELING; LabelingSUPPL13AP2014-07-17STANDARD

Submissions Property Types

SUPPL3Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null0
SUPPL13Null15

CDER Filings

UPSHER SMITH LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72943
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXAPINE","activeIngredients":"AMOXAPINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMOXAPINE","submission":"AMOXAPINE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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