Application Sponsors
ANDA 211314 | STRIDES PHARMA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | 100MG | 0 | GABAPENTIN | GABAPENTIN |
002 | CAPSULE;ORAL | 300MG | 0 | GABAPENTIN | GABAPENTIN |
003 | CAPSULE;ORAL | 400MG | 0 | GABAPENTIN | GABAPENTIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-10-16 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 211314
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-10-16
)
)