Application Sponsors
ANDA 203860 | INVAGEN PHARMS | |
Marketing Status
Application Products
001 | TABLET;ORAL | 800MG | 0 | SEVELAMER CARBONATE | SEVELAMER CARBONATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-10-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2020-04-10 | UNKNOWN |
LABELING; Labeling | SUPPL | 9 | AP | 2020-12-28 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 1 |
SUPPL | 6 | Null | 15 |
SUPPL | 9 | Null | 7 |
TE Codes
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 203860
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"SEVELAMER CARBONATE","activeIngredients":"SEVELAMER CARBONATE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/28\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/10\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-12-28
)
)