Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200647
Company: EXTROVIS
Company: EXTROVIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUDARABINE PHOSPHATE | FLUDARABINE PHOSPHATE | 50MG/2ML (25MG/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 |
---|---|---|---|---|---|---|---|
12/21/2011 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |