ANDA 084500

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #084500

Documents

• Label: 2009-08-14

Application Sponsors

ANDA 084500

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

2MG

0

ESTRACE

ESTRADIOL

FDA Submissions

	ORIG	1	AP	1975-07-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1982-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1983-03-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1985-12-19
LABELING; Labeling	SUPPL	22	AP	1992-09-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1992-11-09
LABELING; Labeling	SUPPL	24	AP	1992-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1992-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1989-07-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1989-07-18
LABELING; Labeling	SUPPL	29	AP	1992-08-10
LABELING; Labeling	SUPPL	30	AP	1993-01-12
LABELING; Labeling	SUPPL	31	AP	1994-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1995-01-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1995-01-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1995-01-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1995-01-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1995-09-11
LABELING; Labeling	SUPPL	37	AP	1997-01-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1997-07-28
LABELING; Labeling	SUPPL	39	AP	1998-10-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2001-01-25
LABELING; Labeling	SUPPL	44	AP	2005-09-12

Submissions Property Types

ORIG	1	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
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
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0
SUPPL	44	Null	0

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84500
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRACE","activeIngredients":"ESTRADIOL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/12\/2005","submission":"SUPPL-44","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":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2005-09-12
        )

)