ANDA 083965

CHARTWELL RX

FDA Drug Application

Application #083965

Documents

• Review: 2003-08-05

Application Sponsors

ANDA 083965

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1977-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	1982-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	1983-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	1983-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	78	AP	1988-09-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	1989-01-18
LABELING; Labeling	SUPPL	81	AP	1988-04-04
LABELING; Labeling	SUPPL	82	AP	1990-02-12
LABELING; Labeling	SUPPL	83	AP	1990-08-03
LABELING; Labeling	SUPPL	84	AP	1990-08-03
LABELING; Labeling	SUPPL	85	AP	1990-08-03
LABELING; Labeling	SUPPL	86	AP	1991-07-25
LABELING; Labeling	SUPPL	87	AP	1991-11-13
LABELING; Labeling	SUPPL	89	AP	1993-07-15
LABELING; Labeling	SUPPL	91	AP	1995-03-13
LABELING; Labeling	SUPPL	92	AP	1995-08-02
LABELING; Labeling	SUPPL	93	AP	1996-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	96	AP	2000-10-06
LABELING; Labeling	SUPPL	97	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	71	Null	0
SUPPL	78	Null	0
SUPPL	80	Null	0
SUPPL	96	Null	0
SUPPL	97	Null	15

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83965
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)