Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210196
Company: AUCTA
Company: AUCTA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIGADRONE | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 06/21/2018 | 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 |
|---|---|---|---|---|---|
| 10/12/2022 | SUPPL-14 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/08/2022 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/02/2020 | SUPPL-7 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/08/2022 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/17/2020 | SUPPL-5 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/08/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/12/2019 | SUPPL-3 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 08/08/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/30/2019 | SUPPL-1 | REMS-Proposal, REMS - MODIFIED - D-N-A |
Label is not available on this site. |
VIGADRONE
FOR SOLUTION;ORAL; 500MG/PACKET
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SABRIL | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | Yes | AA | 022006 | LUNDBECK PHARMS LLC |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 213375 | ALKEM LABS LTD |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 210155 | AMNEAL PHARMS |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 213519 | ANNORA PHARMA |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 213899 | AUROBINDO PHARMA LTD |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 214992 | DEXCEL |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 211481 | DR REDDYS |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 211592 | INVAGEN PHARMS |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 215363 | MSN |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 208218 | PAR PHARM INC |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 213390 | PROPEL PHARMA |
| VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 209824 | TEVA PHARMS USA |
| VIGADRONE | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 210196 | AUCTA |
| VIGPODER | VIGABATRIN | 500MG/PACKET | FOR SOLUTION;ORAL | Prescription | No | AA | 214961 | PYROS PHARMS |