Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215942
Company: TEVA PHARMS INC
Company: TEVA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CABOZANTINIB | CABOZANTINIB | 20MG | TABLET;ORAL | Prescription | None | No | No |
CABOZANTINIB | CABOZANTINIB | 40MG | TABLET;ORAL | Prescription | None | No | No |
CABOZANTINIB | CABOZANTINIB | 60MG | TABLET;ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
10/27/2022 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |