NDA 210565

KALA PHARMS INC

FDA Drug Application

Application #210565

Documents

• Label: 2018-08-23
• Letter: 2018-08-24
• Review: 2019-02-08
• Label: 2020-04-27
• Letter: 2020-04-28

Application Sponsors

NDA 210565

KALA PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

1%

1

INVELTYS

LOTEPREDNOL ETABONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-08-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-04-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

CDER Filings

KALA PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210565
            [companyName] => KALA PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"INVELTYS","activeIngredients":"LOTEPREDNOL ETABONATE","strength":"1%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/24\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210565s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210565s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/22\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210565s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210565Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210565Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/24\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210565s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210565Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-04-24
        )

)