Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | SOLUTION; ORAL | 15MG | 0 | EPRONTIA | TOPIRAMATE |
002 | SOLUTION; ORAL | 25MG | 0 | EPRONTIA | TOPIRAMATE |
003 | SOLUTION; ORAL | 50MG | 0 | EPRONTIA | TOPIRAMATE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2021-11-05 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2022-10-26 | STANDARD |
Submissions Property Types
CDER Filings
AZURITY
cder:Array
(
[0] => Array
(
[ApplNo] => 214679
[companyName] => AZURITY
[docInserts] => ["",""]
[products] => [{"drugName":"EPRONTIA","activeIngredients":"TOPIRAMATE","strength":"15MG","dosageForm":"SOLUTION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"EPRONTIA","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"SOLUTION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"EPRONTIA","activeIngredients":"TOPIRAMATE","strength":"50MG","dosageForm":"SOLUTION; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/05\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214679s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/05\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214679s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214679Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-11-05
)
)