ANDA 085417

CHARTWELL RX

FDA Drug Application

Application #085417

Application Sponsors

ANDA 085417

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

30MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1980-09-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1983-06-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1983-12-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1983-12-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1984-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-05-31
LABELING; Labeling	SUPPL	18	AP	1989-09-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1992-10-16
LABELING; Labeling	SUPPL	21	AP	1997-12-19
LABELING; Labeling	SUPPL	22	AP	1998-04-08
LABELING; Labeling	SUPPL	23	AP	1998-08-19
LABELING; Labeling	SUPPL	24	AP	1998-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2000-10-06

Submissions Property Types

SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	26	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85417
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)