ANDA 085761

CHARTWELL RX

FDA Drug Application

Application #085761

Application Sponsors

ANDA 085761

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

35MG

0

PHENDIMETRAZINE TARTRATE

PHENDIMETRAZINE TARTRATE

FDA Submissions

	ORIG	1	AP	1977-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1983-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1983-06-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1984-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1982-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1988-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1984-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1984-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1988-10-24
LABELING; Labeling	SUPPL	27	AP	1990-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2000-10-06

Submissions Property Types

SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	32	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85761
            [companyName] => CHARTWELL RX
            [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
        )

)