ANDA 088268

CHARTWELL RX

FDA Drug Application

Application #088268

Application Sponsors

ANDA 088268

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

DIETHYLPROPION HYDROCHLORIDE

DIETHYLPROPION HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1983-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-04-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-04-20
LABELING; Labeling	SUPPL	8	AP	1989-02-01
LABELING; Labeling	SUPPL	10	AP	1989-05-01
LABELING; Labeling	SUPPL	11	AP	1991-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-10-06

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	16	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88268
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIETHYLPROPION HYDROCHLORIDE","activeIngredients":"DIETHYLPROPION HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIETHYLPROPION HYDROCHLORIDE","submission":"DIETHYLPROPION HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)