Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209824
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/23/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2026 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 09/12/2024 | SUPPL-13 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/12/2022 | SUPPL-11 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/27/2022 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/02/2020 | SUPPL-9 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/17/2020 | SUPPL-8 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/03/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/12/2019 | SUPPL-5 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/30/2019 | SUPPL-2 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/03/2020 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |