Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201536
Company: APOTEX INC
Company: APOTEX INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | 20MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | 40MG | 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 |
---|---|---|---|---|---|---|---|
07/29/2013 | ORIG-1 | Tentative Approval |
Label is not available on this site. |