Application Sponsors
ANDA 090912 | STRIDES PHARMA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 25MG | 0 | ACARBOSE | ACARBOSE |
002 | TABLET;ORAL | 50MG | 0 | ACARBOSE | ACARBOSE |
003 | TABLET;ORAL | 100MG | 0 | ACARBOSE | ACARBOSE |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2011-07-27 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 90912
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"ACARBOSE","activeIngredients":"ACARBOSE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"ACARBOSE","activeIngredients":"ACARBOSE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ACARBOSE","activeIngredients":"ACARBOSE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ACARBOSE","submission":"ACARBOSE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ACARBOSE","submission":"ACARBOSE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ACARBOSE","submission":"ACARBOSE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)