ANDA 087215

CHARTWELL RX

FDA Drug Application

Application #087215

Application Sponsors

ANDA 087215

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	5	AP	1983-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-12-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1983-12-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1989-05-31
LABELING; Labeling	SUPPL	15	AP	1989-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-10-16
LABELING; Labeling	SUPPL	18	AP	1997-12-19
LABELING; Labeling	SUPPL	19	AP	1998-04-08
LABELING; Labeling	SUPPL	20	AP	1998-08-19
LABELING; Labeling	SUPPL	21	AP	1998-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2000-10-06

Submissions Property Types

SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	23	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87215
            [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
        )

)