ANDA 080136

SUN PHARM INDUSTRIES

FDA Drug Application

Application #080136

Application Sponsors

ANDA 080136

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG

0

ISONIAZID

ISONIAZID

FDA Submissions

	ORIG	1	AP	1970-11-13
LABELING; Labeling	SUPPL	24	AP	1988-12-09
LABELING; Labeling	SUPPL	25	AP	1994-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1992-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1997-03-11
LABELING; Labeling	SUPPL	28	AP	1998-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2000-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2000-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2000-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2000-12-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2001-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2001-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2002-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2002-07-24

Submissions Property Types

SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80136
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISONIAZID","activeIngredients":"ISONIAZID","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISONIAZID","submission":"ISONIAZID","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)