Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076888
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 200MG/100ML (2MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER | FLUCONAZOLE | 400MG/200ML (2MG/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 |
---|---|---|---|---|---|---|---|
03/25/2005 | ORIG-1 | Approval |
Label is not available on this site. |