ANDA 084399

UPSHER SMITH LABS

FDA Drug Application

Application #084399

Application Sponsors

ANDA 084399

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

35MG

0

PHENDIMETRAZINE TARTRATE

PHENDIMETRAZINE TARTRATE

FDA Submissions

	ORIG	1	AP	1981-05-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1985-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1987-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1988-06-10
LABELING; Labeling	SUPPL	16	AP	1990-09-27
LABELING; Labeling	SUPPL	17	AP	1991-09-30
LABELING; Labeling	SUPPL	18	AP	1992-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1993-10-18

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	19	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84399
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENDIMETRAZINE TARTRATE","activeIngredients":"PHENDIMETRAZINE TARTRATE","strength":"35MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENDIMETRAZINE TARTRATE","submission":"PHENDIMETRAZINE TARTRATE","actionType":"35MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)