ANDA 086069

ALLERGAN

FDA Drug Application

Application #086069

Documents

• Review: 2015-05-27
• Label: 2015-05-27

Application Sponsors

ANDA 086069

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

CREAM;VAGINAL

0.01%

0

ESTRACE

ESTRADIOL

FDA Submissions

	ORIG	1	AP	1984-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-10-16
LABELING; Labeling	SUPPL	5	AP	1992-03-11
LABELING; Labeling	SUPPL	7	AP	1991-06-07
LABELING; Labeling	SUPPL	8	AP	1992-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-01-14
LABELING; Labeling	SUPPL	10	AP	1996-12-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-09-09
LABELING; Labeling	SUPPL	12	AP	1998-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-08-11
LABELING; Labeling	SUPPL	16	AP	2000-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-03-27
LABELING; Labeling	SUPPL	18	AP	2005-08-17
LABELING; Labeling	SUPPL	23	AP	2017-06-21	STANDARD
LABELING; Labeling	SUPPL	24	AP	2018-08-15	STANDARD
LABELING; Labeling	SUPPL	26	AP	2022-11-30	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	23	Null	7
SUPPL	24	Null	7
SUPPL	26	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86069
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRACE","activeIngredients":"ESTRADIOL","strength":"0.01%","dosageForm":"CREAM;VAGINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/17\/2005","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/86069s018lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ESTRACE","submission":"ESTRADIOL","actionType":"0.01%","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2005-08-17
        )

)