Application Sponsors
ANDA 077169 | ELITE LABS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE;ORAL | 2.5MG | 0 | ISRADIPINE | ISRADIPINE |
002 | CAPSULE;ORAL | 5MG | 0 | ISRADIPINE | ISRADIPINE |
FDA Submissions
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
ELITE LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 77169
[companyName] => ELITE LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"ISRADIPINE","activeIngredients":"ISRADIPINE","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ISRADIPINE","activeIngredients":"ISRADIPINE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ISRADIPINE","submission":"ISRADIPINE","actionType":"2.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ISRADIPINE","submission":"ISRADIPINE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)