ANDA 083972

SUN PHARM INDUSTRIES

FDA Drug Application

Application #083972

Documents

• Review: 2003-08-05

Application Sponsors

ANDA 083972

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	25MG	0	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE
002	TABLET;ORAL	50MG	0	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE
003	TABLET;ORAL	100MG	0	HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1974-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	109	AP	1982-05-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	140	AP	1982-05-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	142	AP	1982-05-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	148	AP	1984-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	149	AP	1984-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	150	AP	1985-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	151	AP	1985-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	152	AP	1986-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	153	AP	1986-02-05
LABELING; Labeling	SUPPL	161	AP	1989-12-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	162	AP	1991-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	163	AP	1991-04-02
LABELING; Labeling	SUPPL	164	AP	1990-08-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	166	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	168	AP	1992-04-03
LABELING; Labeling	SUPPL	169	AP	1992-08-18
LABELING; Labeling	SUPPL	170	AP	1993-02-12
LABELING; Labeling	SUPPL	171	AP	1994-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	172	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	173	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	174	AP	1998-12-01
LABELING; Labeling	SUPPL	175	AP	2020-08-20	STANDARD

Submissions Property Types

SUPPL	109	Null	0
SUPPL	140	Null	0
SUPPL	142	Null	0
SUPPL	148	Null	0
SUPPL	149	Null	0
SUPPL	150	Null	0
SUPPL	151	Null	0
SUPPL	152	Null	0
SUPPL	153	Null	0
SUPPL	162	Null	0
SUPPL	163	Null	0
SUPPL	166	Null	0
SUPPL	168	Null	0
SUPPL	172	Null	0
SUPPL	173	Null	0
SUPPL	174	Null	0
SUPPL	175	Null	15

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83972
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE","strength":"100MG","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"},{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)