NDA 204251

NOVARTIS

FDA Drug Application

Application #204251

Documents

• Label: 2013-04-23
• Label: 2015-11-12
• Review: 2013-09-26
• Summary Review: 2013-09-26
• Letter: 2013-04-24
• Letter: 2015-11-09

Application Sponsors

NDA 204251

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.2%;1%

1

SIMBRINZA

BRIMONIDINE TARTRATE; BRINZOLAMIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2013-04-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2016-01-15	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2016-06-09	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	5	Null	0
SUPPL	6	Null	15
SUPPL	7	Null	0

CDER Filings

ALCON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204251
            [companyName] => ALCON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SIMBRINZA","activeIngredients":"BRIMONIDINE TARTRATE; BRINZOLAMIDE","strength":"0.2%;1%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/05\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204251s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204251s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/19\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204251s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204251Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204251_simbrinza_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204251Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/09\/2016","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/05\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204251s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204251Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"01\/15\/2016","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/20\/2016","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-06-09
        )

)