ANDA 085683

CHARTWELL RX

FDA Drug Application

Application #085683

Application Sponsors

ANDA 085683

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1977-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1983-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1988-03-24
LABELING; Labeling	SUPPL	41	AP	1989-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1989-05-02
LABELING; Labeling	SUPPL	43	AP	1989-03-24
LABELING; Labeling	SUPPL	44	AP	1990-01-31
LABELING; Labeling	SUPPL	45	AP	1990-08-03
LABELING; Labeling	SUPPL	46	AP	1990-12-04
LABELING; Labeling	SUPPL	47	AP	1991-07-25
LABELING; Labeling	SUPPL	48	AP	1991-11-13
LABELING; Labeling	SUPPL	50	AP	1993-07-15
LABELING; Labeling	SUPPL	52	AP	1995-03-13
LABELING; Labeling	SUPPL	53	AP	1995-08-02
LABELING; Labeling	SUPPL	54	AP	1996-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	2000-10-06
LABELING; Labeling	SUPPL	58	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	36	Null	0
SUPPL	39	Null	0
SUPPL	42	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	15

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85683
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)