Application Sponsors
ANDA 090687 | STRIDES PHARMA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | EQ 0.5MG BASE | 0 | TACROLIMUS | TACROLIMUS |
002 | CAPSULE;ORAL | EQ 1MG BASE | 0 | TACROLIMUS | TACROLIMUS |
003 | CAPSULE;ORAL | EQ 5MG BASE | 0 | TACROLIMUS | TACROLIMUS |
FDA Submissions
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 90687
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TACROLIMUS","activeIngredients":"TACROLIMUS","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 0.5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 1MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TACROLIMUS","submission":"TACROLIMUS","actionType":"EQ 5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)