Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209822
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 | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209822Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209822Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/12/2022 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/27/2022 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/02/2020 | SUPPL-8 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/26/2021 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/17/2020 | SUPPL-6 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 01/26/2021 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/12/2019 | SUPPL-4 | 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. |
VIGABATRIN
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SABRIL | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | Yes | AB | 020427 | LUNDBECK PHARMS LLC |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 210042 | AMNEAL PHARMS |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 215601 | AUROBINDO PHARMA LTD |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 215109 | DEXCEL |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 211539 | DR REDDYS |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 213104 | HIKMA |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 209822 | TEVA PHARMS USA |
| VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 215707 | ZYDUS |