ANDA 088596

CHARTWELL RX

FDA Drug Application

Application #088596

Documents

• Review: 1999-04-13

Application Sponsors

ANDA 088596

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

37.5MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-05-22
LABELING; Labeling	SUPPL	5	AP	1989-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-06-27
LABELING; Labeling	SUPPL	8	AP	1989-06-15
LABELING; Labeling	SUPPL	9	AP	1989-12-15
LABELING; Labeling	SUPPL	10	AP	1990-05-24
LABELING; Labeling	SUPPL	11	AP	1991-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-10-16
LABELING; Labeling	SUPPL	14	AP	1997-12-19
LABELING; Labeling	SUPPL	15	AP	1998-04-08
LABELING; Labeling	SUPPL	16	AP	1998-08-19
LABELING; Labeling	SUPPL	17	AP	1998-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-07-26

Submissions Property Types

SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	13	Null	0
SUPPL	18	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88596
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)