ANDA 089753

SUN PHARM INDUSTRIES

FDA Drug Application

Application #089753

Application Sponsors

ANDA 089753

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	250MG	0	ACETAZOLAMIDE	ACETAZOLAMIDE
002	TABLET;ORAL	125MG	0	ACETAZOLAMIDE	ACETAZOLAMIDE

FDA Submissions

	ORIG	1	AP	1988-06-22
LABELING; Labeling	SUPPL	2	AP	1992-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-01-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-06-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-02-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-08-08
LABELING; Labeling	SUPPL	10	AP	2001-10-25

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89753
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAZOLAMIDE","submission":"ACETAZOLAMIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ACETAZOLAMIDE","submission":"ACETAZOLAMIDE","actionType":"125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)