Documents
Application Sponsors
Marketing Status
Application Products
001 | SUSPENSION;ORAL | 100MG/5ML | 0 | ZONISADE | ZONISAMIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2022-07-15 | STANDARD |
Submissions Property Types
CDER Filings
AZURITY
cder:Array
(
[0] => Array
(
[ApplNo] => 214273
[companyName] => AZURITY
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/214273s000lbl.pdf#page=27"]
[products] => [{"drugName":"ZONISADE","activeIngredients":"ZONISAMIDE","strength":"100MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"07\/15\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214273s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/15\/2022","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\\\/2022\\\/214273s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214273Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2022-07-15
)
)