ANDA 081215

WATSON LABS TEVA

FDA Drug Application

Application #081215

Application Sponsors

ANDA 081215

WATSON LABS TEVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

3MG

0

ESTROPIPATE

ESTROPIPATE

FDA Submissions

	ORIG	1	AP	1993-09-23
LABELING; Labeling	SUPPL	2	AP	1998-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-11-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-11-07
LABELING; Labeling	SUPPL	14	AP	2007-02-23

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81215
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTROPIPATE","activeIngredients":"ESTROPIPATE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESTROPIPATE","submission":"ESTROPIPATE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)