Application Sponsors
| ANDA 203244 | ACI HEALTHCARE LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 800MG | 0 | GABAPENTIN | GABAPENTIN |
| 002 | TABLET;ORAL | 600MG | 0 | GABAPENTIN | GABAPENTIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2013-07-12 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-12-28 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-12-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ACI HEALTHCARE LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203244
[companyName] => ACI HEALTHCARE LTD
[docInserts] => ["",""]
[products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/12\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/28\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/28\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-12-28
)
)