Application Sponsors
| ANDA 209824 | TEVA PHARMS USA | |
Marketing Status
Application Products
| 001 | FOR SOLUTION;ORAL | 500MG/PACKET | 0 | VIGABATRIN | VIGABATRIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-04-23 | STANDARD |
| REMS; REMS | SUPPL | 2 | AP | 2019-05-30 | |
| REMS; REMS | SUPPL | 5 | AP | 2019-09-12 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-08-03 | STANDARD |
| REMS; REMS | SUPPL | 8 | AP | 2020-04-17 | |
| REMS; REMS | SUPPL | 9 | AP | 2020-10-02 | |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-10-27 | STANDARD |
| REMS; REMS | SUPPL | 11 | AP | 2022-10-12 | |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 7 |
TE Codes
CDER Filings
TEVA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 209824
[companyName] => TEVA PHARMS USA
[docInserts] => ["",""]
[products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/17\/2020","submission":"SUPPL-8","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/03\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/12\/2019","submission":"SUPPL-5","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/30\/2019","submission":"SUPPL-2","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/03\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-08-03
)
)