ANDA 085318

CHARTWELL RX

FDA Drug Application

Application #085318

Application Sponsors

ANDA 085318

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	51	AP	1984-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1983-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1983-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1988-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1984-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1984-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1984-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1988-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	1988-06-27
LABELING; Labeling	SUPPL	66	AP	1989-12-13
LABELING; Labeling	SUPPL	67	AP	1992-03-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	2000-10-06

Submissions Property Types

SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	62	Null	0
SUPPL	63	Null	0
SUPPL	72	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85318
            [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
        )

)