ANDA 083923

CHARTWELL RX

FDA Drug Application

Application #083923

Application Sponsors

ANDA 083923

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

8MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1976-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1982-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1983-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1983-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1988-06-27
LABELING; Labeling	SUPPL	37	AP	1989-09-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1989-05-31
LABELING; Labeling	SUPPL	39	AP	1990-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1992-10-16
LABELING; Labeling	SUPPL	43	AP	1997-12-19
LABELING; Labeling	SUPPL	44	AP	1998-04-08
LABELING; Labeling	SUPPL	45	AP	1999-06-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2000-10-06

Submissions Property Types

SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	35	Null	0
SUPPL	38	Null	0
SUPPL	41	Null	0
SUPPL	47	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83923
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)