Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079033
Company: MYLAN INSTITUTIONAL
Company: MYLAN INSTITUTIONAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FOMEPIZOLE | FOMEPIZOLE | 1.5GM/1.5ML (1GM/ML) | 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 |
---|---|---|---|---|---|---|---|
04/07/2009 | ORIG-1 | Approval |
Label is not available on this site. |