Drugs@FDA: FDA Approved Drug Products
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)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209822Orig1s000ltr.pdf |
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 | 209822 | TEVA PHARMS USA |
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