Application Sponsors
ANDA 211928 | STRIDES PHARMA | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 250MG | 0 | ETHOSUXIMIDE | ETHOSUXIMIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-02-19 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2022-08-25 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2022-08-25 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 7 |
TE Codes
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 211928
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"ETHOSUXIMIDE","activeIngredients":"ETHOSUXIMIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/19\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-02-19
)
)