Application Sponsors
ANDA 204793 | HETERO LABS LTD V | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE;ORAL | 4MG | 0 | SILODOSIN | SILODOSIN |
002 | CAPSULE;ORAL | 8MG | 0 | SILODOSIN | SILODOSIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-02-14 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
HETERO LABS LTD V
cder:Array
(
[0] => Array
(
[ApplNo] => 204793
[companyName] => HETERO LABS LTD V
[docInserts] => ["",""]
[products] => [{"drugName":"SILODOSIN","activeIngredients":"SILODOSIN","strength":"4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SILODOSIN","activeIngredients":"SILODOSIN","strength":"8MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-02-14
)
)