Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205557
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EPTIFIBATIDE | EPTIFIBATIDE | 2MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
EPTIFIBATIDE | EPTIFIBATIDE | 75MG/100ML | INJECTABLE;INJECTION | Discontinued | 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 |
---|---|---|---|---|---|---|---|
11/06/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |