ANDA 083633

SUN PHARM INDUSTRIES

FDA Drug Application

Application #083633

Application Sponsors

ANDA 083633

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

300MG

0

ISONIAZID

ISONIAZID

FDA Submissions

	ORIG	1	AP	1976-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-07-19
LABELING; Labeling	SUPPL	9	AP	1988-12-09
LABELING; Labeling	SUPPL	10	AP	1994-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1997-03-11
LABELING; Labeling	SUPPL	13	AP	1998-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-07-24

Submissions Property Types

SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83633
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISONIAZID","activeIngredients":"ISONIAZID","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISONIAZID","submission":"ISONIAZID","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)