NDA 020655

ALLERGAN

FDA Drug Application

Application #020655

Documents

• Letter: 2002-04-05
• Label: 2003-12-01
• Label: 2002-04-05
• Letter: 2003-11-26
• Letter: 2005-05-20
• Label: 2005-05-20
• Review: 2004-05-27
• Label: 2017-11-02
• Letter: 2020-03-31
• Label: 2020-03-31

Application Sponsors

NDA 020655

ALLERGAN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR	0	ALORA	ESTRADIOL
002	FILM, EXTENDED RELEASE;TRANSDERMAL	0.075MG/24HR	0	ALORA	ESTRADIOL
003	FILM, EXTENDED RELEASE;TRANSDERMAL	0.1MG/24HR	0	ALORA	ESTRADIOL
004	FILM, EXTENDED RELEASE;TRANSDERMAL	0.025MG/24HR	0	ALORA	ESTRADIOL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1996-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-11-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	1999-06-04	STANDARD
LABELING; Labeling	SUPPL	5	AP	2000-04-14	STANDARD
LABELING; Labeling	SUPPL	6	AP	2003-11-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-10-02	STANDARD
LABELING; Labeling	SUPPL	8	AP	2002-04-05	STANDARD
LABELING; Labeling	SUPPL	11	AP	2005-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2013-08-30	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-03-30	STANDARD
LABELING; Labeling	SUPPL	20	AP	2017-11-01	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	7
SUPPL	20	Null	15

TE Codes

001	Prescription	BX
002	Prescription	BX
003	Prescription	BX
004	Prescription	BX

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20655
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALORA","activeIngredients":"ESTRADIOL","strength":"0.05MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALORA","activeIngredients":"ESTRADIOL","strength":"0.075MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALORA","activeIngredients":"ESTRADIOL","strength":"0.1MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALORA","activeIngredients":"ESTRADIOL","strength":"0.025MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/30\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020655Orig1s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020655s020lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2005","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020655s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2003","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20655slr006_alora_lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2002","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20655s8lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALORA","submission":"ESTRADIOL","actionType":"0.05MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ALORA","submission":"ESTRADIOL","actionType":"0.075MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ALORA","submission":"ESTRADIOL","actionType":"0.1MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ALORA","submission":"ESTRADIOL","actionType":"0.025MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-03-30
        )

)