Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091031
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFOTETAN | CEFOTETAN DISODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
CEFOTETAN | CEFOTETAN DISODIUM | EQ 2GM BASE/VIAL | 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 |
---|---|---|---|---|---|---|---|
10/26/2011 | ORIG-1 | Approval |
Label is not available on this site. |