Application Sponsors
| ANDA 211481 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
| 001 | FOR SOLUTION;ORAL | 500MG/PACKET | 0 | VIGABATRIN | VIGABATRIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-11-20 | STANDARD |
| REMS; REMS | SUPPL | 2 | AP | 2019-09-12 | |
| REMS; REMS | SUPPL | 4 | AP | 2020-04-17 | |
| REMS; REMS | SUPPL | 6 | AP | 2020-10-02 | |
| REMS; REMS | SUPPL | 8 | AP | 2022-10-12 | |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 8 | Null | 15 |
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 211481
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"VIGABATRIN","activeIngredients":"VIGABATRIN","strength":"500MG\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/02\/2020","submission":"SUPPL-6","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2020","submission":"SUPPL-4","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/12\/2019","submission":"SUPPL-2","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/30\/2019","submission":"SUPPL-1","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-10-02
)
)