Application Sponsors
| ANDA 206402 | ALKEM LABS LTD | |
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 | 2015-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2021-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2021-04-29 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2022-03-31 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 20 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ALKEM LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 206402
[companyName] => ALKEM LABS LTD
[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":"12\/23\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"01\/09\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2017-01-09
)
)