ANDA 072878

UPSHER SMITH LABS

FDA Drug Application

Application #072878

Application Sponsors

ANDA 072878

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG

0

AMOXAPINE

AMOXAPINE

FDA Submissions

	ORIG	1	AP	1991-06-28
LABELING; Labeling	SUPPL	2	AP	1993-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-01-24
LABELING; Labeling	SUPPL	4	AP	1995-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-03-23
LABELING; Labeling	SUPPL	8	AP	2001-05-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-03-25
LABELING; Labeling	SUPPL	13	AP	2014-07-17	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	15

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72878
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXAPINE","activeIngredients":"AMOXAPINE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMOXAPINE","submission":"AMOXAPINE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)