Documents
Application Sponsors
NDA 210933 | KALA PHARMS INC | |
Marketing Status
Application Products
001 | SOLUTION;OPHTHALMIC | 0.25% | 2 | EYSUVIS | LOTEPREDNOL ETABONATE |
FDA Submissions
TYPE 10; Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated | ORIG | 1 | AP | 2020-10-26 | STANDARD |
Submissions Property Types
CDER Filings
KALA PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210933
[companyName] => KALA PHARMS INC
[docInserts] => ["",""]
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[labels] => [{"actionDate":"10\/26\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210933s000lbl.pdf\"}]","notes":""}]
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[supplements] =>
[actionDate] => 2020-10-26
)
)