Application Sponsors
ANDA 091356 | STRIDES PHARMA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE;ORAL | 0.25MCG | 0 | CALCITRIOL | CALCITRIOL |
002 | CAPSULE;ORAL | 0.5MCG | 0 | CALCITRIOL | CALCITRIOL |
FDA Submissions
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 91356
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"CALCITRIOL","activeIngredients":"CALCITRIOL","strength":"0.25MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CALCITRIOL","activeIngredients":"CALCITRIOL","strength":"0.5MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CALCITRIOL","submission":"CALCITRIOL","actionType":"0.25MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CALCITRIOL","submission":"CALCITRIOL","actionType":"0.5MCG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)