Application Sponsors
ANDA 215469 | STRIDES PHARMA | |
Marketing Status
None (Tentative Approval) | 001 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-01-06 | STANDARD |
Submissions Property Types
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 215469
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE","activeIngredients":"SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE","strength":"17.5G;3013G;1.6G","dosageForm":"SOLUTION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/06\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-01-06
)
)