ANDA 085321

CHARTWELL RX

FDA Drug Application

Application #085321

Application Sponsors

ANDA 085321

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

35MG

0

CAM-METRAZINE

PHENDIMETRAZINE TARTRATE

FDA Submissions

	ORIG	1	AP	1977-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1983-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1983-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1983-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1983-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1988-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1984-04-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1984-04-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1984-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1988-10-24
LABELING; Labeling	SUPPL	53	AP	1989-12-13
LABELING; Labeling	SUPPL	54	AP	1991-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	2000-10-06

Submissions Property Types

SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	59	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85321
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAM-METRAZINE","activeIngredients":"PHENDIMETRAZINE TARTRATE","strength":"35MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CAM-METRAZINE","submission":"PHENDIMETRAZINE TARTRATE","actionType":"35MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)