Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091299
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOROURACIL | FLUOROURACIL | 2.5GM/50ML (50MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
FLUOROURACIL | FLUOROURACIL | 5GM/100ML (50MG/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 |
---|---|---|---|---|---|---|---|
05/02/2011 | ORIG-1 | Approval |
Label is not available on this site. |