NDA 022315

ALLERGAN

FDA Drug Application

Application #022315

Documents

• Letter: 2009-06-23
• Letter: 2012-02-29
• Letter: 2012-09-10
• Letter: 2014-02-11
• Label: 2009-06-22
• Label: 2014-02-10
• Letter: 2010-09-07
• Letter: 2010-09-29
• Letter: 2014-06-30
• Letter: 2014-10-01
• Label: 2010-09-29
• Label: 2012-02-28
• Label: 2012-09-11
• Label: 2014-07-01
• Label: 2014-09-30
• Review: 2009-10-29
• Summary Review: 2009-10-29
• Review: 2017-05-17
• Letter: 2018-05-16
• Label: 2018-05-17
• Letter: 2020-10-23
• Label: 2020-10-23
• Label: 2022-12-21
• Letter: 2022-12-21

Application Sponsors

NDA 022315

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

IMPLANT;INTRAVITREAL

0.7MG

1

OZURDEX

DEXAMETHASONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2009-06-17	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2010-08-31	UNKNOWN
EFFICACY; Efficacy	SUPPL	3	AP	2010-09-24	STANDARD
LABELING; Labeling	SUPPL	5	AP	2012-02-24	STANDARD
LABELING; Labeling	SUPPL	7	AP	2012-09-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-02-07	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2014-06-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	2014-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2016-02-05	PRIORITY
LABELING; Labeling	SUPPL	12	AP	2018-05-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-10-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-12-19	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	5	Null	7
SUPPL	7	Null	6
SUPPL	8	Null	6
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	0
SUPPL	12	Null	15
SUPPL	13	Null	6
SUPPL	16	Null	6

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22315
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OZURDEX","activeIngredients":"DEXAMETHASONE","strength":"0.7MG","dosageForm":"IMPLANT;INTRAVITREAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/15\/2018","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022315s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022315s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2014","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022315s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2014","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022315s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022315s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2012","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022315s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2010","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022315s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022315lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OZURDEX","submission":"DEXAMETHASONE","actionType":"0.7MG","submissionClassification":"IMPLANT;INTRAVITREAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-05-15
        )

)