ANDA 084897

CHARTWELL RX

FDA Drug Application

Application #084897

Application Sponsors

ANDA 084897

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG;15MG;0.1MG

0

CAM-AP-ES

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

FDA Submissions

	ORIG	1	AP	1979-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1983-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1988-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1988-06-02
LABELING; Labeling	SUPPL	27	AP	1989-05-09
LABELING; Labeling	SUPPL	28	AP	1991-03-15
LABELING; Labeling	SUPPL	29	AP	1992-02-11
LABELING; Labeling	SUPPL	30	AP	1992-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2000-10-06
LABELING; Labeling	SUPPL	36	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	18	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	15

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84897
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAM-AP-ES","activeIngredients":"HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE","strength":"25MG;15MG;0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CAM-AP-ES","submission":"HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE","actionType":"25MG;15MG;0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)