Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209538
Company: TARO PHARM INDS LTD
Company: TARO PHARM INDS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PERAMPANEL | PERAMPANEL | 2MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
PERAMPANEL | PERAMPANEL | 4MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
PERAMPANEL | PERAMPANEL | 6MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
PERAMPANEL | PERAMPANEL | 8MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
PERAMPANEL | PERAMPANEL | 10MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
PERAMPANEL | PERAMPANEL | 12MG | TABLET;ORAL | None (Tentative Approval) | None | 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 |
---|---|---|---|---|---|---|---|
06/17/2021 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |