Documents
Application Sponsors
NDA 210565 | KALA PHARMS INC | |
Marketing Status
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
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
)
)