Application Sponsors
| ANDA 202764 | INVAGEN PHARMS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 600MG | 0 | GABAPENTIN | GABAPENTIN |
| 002 | TABLET;ORAL | 800MG | 0 | GABAPENTIN | GABAPENTIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2012-10-16 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2014-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-06-02 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-06-02 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-06-02 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2021-06-02 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2021-06-02 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2021-06-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 202764
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/16\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/25\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2014-09-25
)
)