Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206576
Company: TWI PHARMS INC
Company: TWI PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET, EXTENDED RELEASE;ORAL | None (Tentative Approval) | None | No | No |
OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
11/29/2018 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |