ANDA 081295

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #081295

Documents

• Label: 2009-08-14

Application Sponsors

ANDA 081295

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.5MG

0

ESTRACE

ESTRADIOL

FDA Submissions

	ORIG	1	AP	1993-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-01-07
LABELING; Labeling	SUPPL	3	AP	1997-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-10-27
LABELING; Labeling	SUPPL	7	AP	1997-01-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1997-07-28
LABELING; Labeling	SUPPL	9	AP	1998-10-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-01-25
LABELING; Labeling	SUPPL	14	AP	2005-09-12

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
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
SUPPL	11	Null	0
SUPPL	14	Null	0

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81295
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRACE","activeIngredients":"ESTRADIOL","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/12\/2005","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/081295s014,084499s042,084500s044lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ESTRACE","submission":"ESTRADIOL","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2005-09-12
        )

)