Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215707
Company: ZYDUS LIFESCIENCES
Company: ZYDUS LIFESCIENCES
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 |
---|---|---|---|---|---|---|---|
01/19/2022 | 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-1 | 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 | 215519 | PROPEL PHARMA |
VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 209822 | TEVA PHARMS USA |
VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 214749 | UPSHER SMITH LABS |
VIGABATRIN | VIGABATRIN | 500MG | TABLET;ORAL | Prescription | No | AB | 215707 | ZYDUS LIFESCIENCES |