Application Sponsors
Marketing Status
Application Products
001 | CAPSULE;ORAL | 0.5MG;0.4MG | 0 | DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE | DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-05-24 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ZYDUS PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 207769
[companyName] => ZYDUS PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE","activeIngredients":"DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE","strength":"0.5MG;0.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-05-24
)
)