NDA 022212

NOVARTIS

FDA Drug Application

Application #022212

Documents

• Letter: 2008-06-24
• Letter: 2009-03-25
• Letter: 2012-06-15
• Letter: 2012-11-28
• Letter: 2013-05-16
• Label: 2008-06-24
• Label: 2012-06-18
• Label: 2013-05-21
• Label: 2016-08-02
• Review: 2008-07-25
• Letter: 2013-03-26
• Letter: 2016-08-02
• Label: 2012-12-10
• Label: 2013-03-26
• Summary Review: 2008-07-25
• Pediatric Written Request: 2009-02-18
• Pediatric Amendment 1: 2011-09-12
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Review: 2020-05-08

Application Sponsors

NDA 022212

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

EMULSION;OPHTHALMIC

0.05%

1

DUREZOL

DIFLUPREDNATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2008-06-23	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2012-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2012-11-27	PRIORITY
EFFICACY; Efficacy	SUPPL	11	AP	2013-03-22	PRIORITY
LABELING; Labeling	SUPPL	12	AP	2013-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2016-04-11	PRIORITY
LABELING; Labeling	SUPPL	16	AP	2016-07-29	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	7
SUPPL	10	Null	0
SUPPL	11	Null	6
SUPPL	12	Null	15
SUPPL	15	Null	0
SUPPL	16	Null	15

TE Codes

001

Prescription

AB

CDER Filings

NOVARTIS

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            [ApplNo] => 22212
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUREZOL","activeIngredients":"DIFLUPREDNATE","strength":"0.05%","dosageForm":"EMULSION;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/29\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022212s016lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2016","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022212s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2013","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022212s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2013","submission":"SUPPL-11","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022212s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2012","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022212s010lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/13\/2012","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022212s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022212lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DUREZOL","submission":"DIFLUPREDNATE","actionType":"0.05%","submissionClassification":"EMULSION;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-07-29
        )

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