ANDA 088847

CHARTWELL RX

FDA Drug Application

Application #088847

Application Sponsors

ANDA 088847

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1985-02-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1991-01-28
LABELING; Labeling	SUPPL	7	AP	1991-01-28
LABELING; Labeling	SUPPL	8	AP	1992-02-14
LABELING; Labeling	SUPPL	10	AP	1992-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-10-06

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	13	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88847
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDRALAZINE HYDROCHLORIDE","submission":"HYDRALAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)