Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | SOLUTION;ORAL | 17.5GM/BOT;3.13GM/BOT;1.6GM/BOT | 0 | SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE | SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-06-15 | STANDARD |
Submissions Property Types
CDER Filings
ANNORA PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 212903
[companyName] => ANNORA PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE","activeIngredients":"SODIUM SULFATE;POTASSIUM SULFATE;MAGNESIUM SULFATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/15\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-06-15
)
)