Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 211333
Company: VISTAPHARM
Company: VISTAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FELBAMATE | FELBAMATE | 600MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 05/31/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FELBAMATE
SUSPENSION;ORAL; 600MG/5ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FELBAMATE | FELBAMATE | 600MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 202385 | AMNEAL PHARMS |
| FELBAMATE | FELBAMATE | 600MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 206314 | TARO |
| FELBAMATE | FELBAMATE | 600MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 211333 | VISTAPHARM |
| FELBATOL | FELBAMATE | 600MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 020189 | MYLAN SPECIALITY LP |
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