ANDA 088576

CHARTWELL RX

FDA Drug Application

Application #088576

Application Sponsors

ANDA 088576

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

18.75MG

0

PHENTERMINE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-05-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-06-27
LABELING; Labeling	SUPPL	6	AP	1989-05-02
LABELING; Labeling	SUPPL	7	AP	1990-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1992-10-16
LABELING; Labeling	SUPPL	11	AP	1997-12-19
LABELING; Labeling	SUPPL	12	AP	1998-04-08
LABELING; Labeling	SUPPL	13	AP	1998-08-19
LABELING; Labeling	SUPPL	14	AP	1998-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-10-06

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	16	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88576
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"18.75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENTERMINE HYDROCHLORIDE","submission":"PHENTERMINE HYDROCHLORIDE","actionType":"18.75MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)