ANDA 085319

CHARTWELL RX

FDA Drug Application

Application #085319

Application Sponsors

ANDA 085319

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

8MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1977-03-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1982-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1986-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1983-02-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1983-05-12
LABELING; Labeling	SUPPL	25	AP	1990-01-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1989-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1992-10-16
LABELING; Labeling	SUPPL	32	AP	1997-12-19
LABELING; Labeling	SUPPL	33	AP	1998-04-08
LABELING; Labeling	SUPPL	34	AP	1999-06-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2000-10-06

Submissions Property Types

SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	36	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85319
            [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
        )

)