Documents
Application Sponsors
NDA 210864 | SEDOR PHARMS LLC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | SOLUTION;INTRAVENOUS | EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML) | 1 | SESQUIENT | FOSPHENYTOIN SODIUM |
002 | SOLUTION;INTRAVENOUS | EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML) | 1 | SESQUIENT | FOSPHENYTOIN SODIUM |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2020-11-05 | STANDARD |
Submissions Property Types
CDER Filings
SEDOR PHARMS LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 210864
[companyName] => SEDOR PHARMS LLC
[docInserts] => ["",""]
[products] => [{"drugName":"SESQUIENT","activeIngredients":"FOSPHENYTOIN SODIUM","strength":"EQ 100MG PHENYTOIN NA\/2ML (EQ 50MG PHENYTOIN NA\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SESQUIENT","activeIngredients":"FOSPHENYTOIN SODIUM","strength":"EQ 500MG PHENYTOIN NA\/10ML (EQ 50MG PHENYTOIN NA\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/05\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210864s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/05\/2020","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\\\/2020\\\/210864s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210864Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-11-05
)
)