Application Sponsors
ANDA 206342 | POLYGEN PHARMS | |
Marketing Status
Application Products
001 | TABLET;ORAL | 37.5MG | 0 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-11-18 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
POLYGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 206342
[companyName] => POLYGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"PHENTERMINE HYDROCHLORIDE","activeIngredients":"PHENTERMINE HYDROCHLORIDE","strength":"37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/31\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2017-05-31
)
)