ANDA 087805

CHARTWELL RX

FDA Drug Application

Application #087805

Documents

• Review: 1999-04-13

Application Sponsors

ANDA 087805

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

37.5MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1982-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1983-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1989-05-31
LABELING; Labeling	SUPPL	11	AP	1989-05-02
LABELING; Labeling	SUPPL	12	AP	1990-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-06-30
LABELING; Labeling	SUPPL	16	AP	1997-12-19
LABELING; Labeling	SUPPL	17	AP	1998-04-08
LABELING; Labeling	SUPPL	18	AP	1998-08-19
LABELING; Labeling	SUPPL	19	AP	1998-11-03
LABELING; Labeling	SUPPL	20	AP	1999-10-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2000-10-06

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	22	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87805
            [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
        )

)