Application Sponsors
ANDA 212033 | YICHANG HUMANWELL | |
Marketing Status
Application Products
001 | TABLET;ORAL | 220MG | 0 | NAPROXEN SODIUM | NAPROXEN SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-08-30 | STANDARD |
Submissions Property Types
CDER Filings
YICHANG HUMANWELL
cder:Array
(
[0] => Array
(
[ApplNo] => 212033
[companyName] => YICHANG HUMANWELL
[docInserts] => ["",""]
[products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"220MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/29\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-29
)
)