NDA 201923

ALIMERA SCIENCES INC

FDA Drug Application

Application #201923

Documents

• Review: 2016-03-18
• Letter: 2014-09-29
• Label: 2014-09-30
• Label: 2017-03-09
• Letter: 2017-03-14

Application Sponsors

NDA 201923

ALIMERA SCIENCES INC

Marketing Status

• Prescription: 001

Application Products

001

IMPLANT;INTRAVITREAL

0.19MG

1

ILUVIEN

FLUOCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2014-09-26	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2017-03-08	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15

CDER Filings

ALIMERA SCIENCES INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201923
            [companyName] => ALIMERA SCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ILUVIEN","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.19MG","dosageForm":"IMPLANT;INTRAVITREAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/08\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201923s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201923s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/26\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201923s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201923Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/201923Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/08\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201923s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201923Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"05\/18\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-03-08
        )

)