Application Sponsors
ANDA 206706 | POLYGEN PHARMS | |
Marketing Status
Application Products
001 | TABLET;ORAL | 50MG | 0 | TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-07-02 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
POLYGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 206706
[companyName] => POLYGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"TRAMADOL HYDROCHLORIDE","activeIngredients":"TRAMADOL HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/02\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-07-02
)
)