Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 25MG | 0 | METHAZOLAMIDE | METHAZOLAMIDE |
002 | TABLET;ORAL | 50MG | 0 | METHAZOLAMIDE | METHAZOLAMIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-10-18 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
ZENARA
cder:Array
(
[0] => Array
(
[ApplNo] => 215615
[companyName] => ZENARA
[docInserts] => ["",""]
[products] => [{"drugName":"METHAZOLAMIDE","activeIngredients":"METHAZOLAMIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHAZOLAMIDE","activeIngredients":"METHAZOLAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-10-18
)
)