Documents
Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;OPHTHALMIC | 0.002%(0.02MG/ML) | 0 | OMLONTI | OMIDENEPAG ISOPROPYL |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2022-09-22 | STANDARD |
Submissions Property Types
CDER Filings
SANTEN
cder:Array
(
[0] => Array
(
[ApplNo] => 215092
[companyName] => SANTEN
[docInserts] => ["",""]
[products] => [{"drugName":"OMLONTI","activeIngredients":"OMIDENEPAG ISOPROPYL","strength":"0.002%(0.02MG\/ML)","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"09\/22\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215092s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215092s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215092Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2022-09-22
)
)