ANDA 089582

SUN PHARM INDS INC

FDA Drug Application

Application #089582

Application Sponsors

ANDA 089582

SUN PHARM INDS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

1.5MG

0

ORTHO-EST

ESTROPIPATE

FDA Submissions

	ORIG	1	AP	1991-07-17
LABELING; Labeling	SUPPL	2	AP	1993-06-21
LABELING; Labeling	SUPPL	3	AP	1993-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-05-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-02-22
LABELING; Labeling	SUPPL	6	AP	1996-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-03-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-03-19
LABELING; Labeling	SUPPL	13	AP	2003-06-11
LABELING; Labeling	SUPPL	15	AP	2003-08-26
LABELING; Labeling	SUPPL	19	AP	2004-07-21

Submissions Property Types

SUPPL	1	Null	1
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89582
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORTHO-EST","activeIngredients":"ESTROPIPATE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ORTHO-EST","submission":"ESTROPIPATE","actionType":"1.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)